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Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia (V-DIFFERENCE)

Primary Purpose

Hypercholesterolemia

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Inclisiran Sodium
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Inclisiran, rosuvastatin, PCSK9, dyslipidemia, angina pectoris, peripheral artery disease, cardiovascular disease, LDL-C

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  2. Male or female participants ≥18 years of age.
  3. Participants meeting one of the following CV category:

    •Very high risk participants with the following: A. Documented Atherosclerotic Cardiovascular Disease (ASCVD) i) Acute Coronary Syndrome: Unstable angina or myocardial infarction ii) Stable angina iii) Unequivocally documented ASCVD upon prior imaging v) Stroke and Transient Ischaemic Attack (TIA) vi) Peripheral Artery Disease (PAD) B. Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major risk factors, or early onset of Type 1 DM of long duration (> 20 years) C. A calculated SCORE2 ≥ 7.5% for age < 50 years; SCORE2 ≥ 10% for age 50-69 years; SCORE2-OP ≥ 15% for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD D. Pre-existing diagnosis of heterozygous familial hypercholesterolemia (HeFH) with ASCVD or with another major risk factor.

    •High risk participants with the following: A. Markedly elevated single risk factors, in particular total cholesterol > 8mmol/L (> 310 mg/dL), LDL-C > 4.9 mmol/dL (> 190 mg/dL), or blood pressure ≥ 180/110 mmHg B. Pre-existing diagnosis of HeFH without other major risk factors C. DM without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration ≥ 10 years or other additional risk factor D. Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2) E. A calculated SCORE2 2.5 to <7.5% for age under 50 years; SCORE2 5 to <10% for age 50-69 years; SCORE2-OP 7.5 to <15% for age ≥70 years to estimate 10-year risk of fatal and non-fatal CVD as defined by the cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020)

  4. LDL-C levels:

    1. in participants with very high cardiovascular risk: serum LDL-C ≥1.4
    2. in participants with high cardiovascular risk: serum LDL-C ≥1.8 mmol/l (≥70 mg/dL)
    3. Participant on a stable dose of a statin for ≥ 30 days.
    4. Up to 20% of participants can be on a stable dose (for ≥ 30 days) of another LLT on top of statin such as a cholesterol absorbing inhibitor or a bile acid sequestrant, or alternatively, an adenosine triphosphate citrate lyase (ACL) inhibitor, as indicated.
  5. Fasting triglyceride < 400 mg/dL (< 4.52 mmol/L).

    At Baseline:

  6. Fasting triglyceride < 400 mg/dL (< 4.52 mmol/L).
  7. Before randomization, despite being treated with the individual MTD of a statin for ≥ 30 days and, if applicable, with another LLT on top of statin (stable for ≥ 30 days),

    1. in participants with very high cardiovascular risk: serum LDL-C ≥ 1.4mmol/L (≥ 55mg/dL).
    2. in participants with high cardiovascular risk: serum LDL-C ≥ 1.8mmol/L (≥ 70mg/dL).

Key Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study.

  1. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 2 years at screening or baseline visit.
  2. Participants on more than one other lipid-lowering drug on top of statin at screening visit.
  3. Pre-existing diagnosis of homozygous familial hypercholesterolemia at screening or baseline visit.
  4. Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome at screening or baseline visit.
  5. Previous (within 90 days of screening), current or planned treatment with a monoclonal antibody (mAb) directed towards PCSK9 (e.g. evolocumab, alirocumab) at screening or baseline visit.
  6. Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within 2 years prior to screening or baseline visit.
  7. Previous, current or planned treatment with LDL-apheresis at screening or baseline visit.
  8. Participants with known intolerance to rosuvastatin at screening or baseline visit.
  9. History of hypersensitivity to any of the study treatments, inclisiran or rosuvastatin, or its excipients or to drugs of similar chemical classes at screening or baseline visit.
  10. Participants taking gemfibrozil at screening or baseline visit.
  11. Liver and CK: (a) Active liver disease defined as any current infectious, neoplastic, or metabolic pathology of the liver or (b) unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation > 2x ULN (except for participants with Gilbert's syndrome), or (c) creatine kinase (CK) >5x ULN at screening or baseline visit.
  12. Participant with severe renal impairment defined by eGFR <30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at screening or baseline visit.
  13. Acute coronary syndrome, ischemic stroke or TIA, coronary revascularization or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 3 months prior to the screening or baseline visit.
  14. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization within the study duration.
  15. Heart failure New York Heart Association (NYHA) class IV at screening or baseline visit.
  16. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 3 years prior to screening or baseline visit.
  17. Participant with myopathy at screening or baseline visit.
  18. Participant receiving concomitant ciclosporin at screening or baseline visit.
  19. Participants that are predisposed to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures).
  20. Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose-malabsorption.
  21. Unwillingness or inability (e.g. physical or cognitive) to comply with study procedures (including study visits, fasting blood draws and compliance with study treatment regimens), and medication administration (injections) and schedule. Participant should be able and willing to read, understand and answer questionnaires.
  22. Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study at screening or baseline visit.
  23. Use of other investigational drugs within 5 half-lives, 30 days or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer or longer if required by local regulation, prior to screening visit.
  24. Pregnant or nursing (lactating) women at screening or baseline visit.
  25. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment, which includes rosuvastatin, and for 5 days (= 5 times the terminal half-life of rosuvastatin) after stopping medication. Highly effective contraception methods include:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    • Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
    • Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.

In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms). Women are considered not of child bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessments and she is considered not of child bearing potential.

If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the local ICF.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inclisiran sodium 300 mg s.c. + open label rosuvastatin

Corresponding placebo + open label rosuvastatin

Arm Description

Participants will be randomized at the baseline visit (Day 1) to one of the following two double-blind treatment groups in a 1:1 ratio. Inclisiran sodium 300 mg s.c. Corresponding placebo Open label study treatment rosuvastatin: all participants will receive rosuvastatin, starting at the lowest indicated dose and titrating up until they reach their individual LDL-C target or MTD, whichever occurs first.

Participants will be randomized at the baseline visit (Day 1) to one of the following two double-blind treatment groups in a 1:1 ratio. Inclisiran sodium 300 mg s.c. Corresponding placebo Open label study treatment rosuvastatin: all participants will receive rosuvastatin, starting at the lowest indicated dose and titrating up until they reach their individual LDL-C target or MTD, whichever occurs first.

Outcomes

Primary Outcome Measures

Proportion of participants achieving individual LDL-C target (<55 mg/dL or <70 mg/dL)
Inclisiran on top of ongoing individually optimized lipid-lowering therapy (LLT) compared to placebo on top of ongoing individually optimized LLT on reaching a participant's individual LDL-C target as measured by the proportion of participants achieving individual LDL-C target (<55mg/dL or < 70 mg/dL) at day 90.

Secondary Outcome Measures

Relative percentage change from baseline to mean LDL-C level over the double-blind treatment period
Inclisiran on top of ongoing individually optimized LLT compared to placebo on top of ongoing individualized LLT on: reducing mean LDL-C levels over the double-blind study period.
Proportion of participants experiencing at least one Muscle-related adverse event (AE) as defined in the Standardized MedDRA Queries (SMQ)
Participants experiencing at least one muscle-related AE as defined in the SMQ rhabdomyolysis/myopathy from day 1 to day 360.
Proportion of participants experiencing self-reported pain
Annualized number of days pain is experienced using pain diary
Change from baseline in Short-Form Brief Pain Inventory (SF-BPI) pain severity score to Day 360
Pain-related quality of life at day 360 using the SF-BPI
Change from baseline in Short-Form Brief Pain Inventory (SF-BPI) pain interference score at Day 360
Pain related quality of life at day 360 using the SF-BPI
Proportion of participants with clinically relevant change in Short-Form Brief Pain Inventory (SF-BPI) pain severity score from baseline to day 360.
Pain-related quality of life at day 360 using the SF-BPI
Proportion of participants with clinically relevant change in Short-Form Brief Pain Inventory (SF-BPI) pain interference score from baseline to day 360
Pain-related quality of life at day 360 using the SF-BPI

Full Information

First Posted
December 13, 2021
Last Updated
September 19, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05192941
Brief Title
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia
Acronym
V-DIFFERENCE
Official Title
Efficacy, Safety, Tolerability and Quality of Life of Ongoing Individually Optimized Lipid-lowering Therapy With or Without Inclisiran (KJX839) - a Randomized, Placebo-controlled, Double-blind Multicenter Phase IV Study in Participants With Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
February 14, 2025 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia
Detailed Description
The purpose of this study is to demonstrate the superiority of inclisiran compared to placebo, both on top of ongoing individually optimized lipid-lowering therapy (LLT), on reaching a participant's LDL-C target (< 55 mg/dL or < 70 mg/dL, depending on the cardiovascular risk category, according to the 2019 ESC/EAS guidelines for the management of dyslipidemias as well as on patient-relevant safety, tolerability outcomes and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Inclisiran, rosuvastatin, PCSK9, dyslipidemia, angina pectoris, peripheral artery disease, cardiovascular disease, LDL-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double-blind investigational treatment inclisiran/placebo: subcutaneous injections of inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) or placebo, in 1.5 mL solution. Open label study treatment rosuvastatin: all participants will receive rosuvastatin, starting at the lowest indicated dose and titrating up until they reach their individual LDL-C target or MTD, whichever occurs first.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will be randomized at the baseline visit (Day 1) to one of the following two double-blind treatment groups in a 1:1 ratio. Inclisiran sodium 300 mg s.c. Corresponding placebo Each participant will receive one injection of blinded inclisiran or placebo on Day 1, a second injection of blinded inclisiran or placebo on Day 90 and a subsequent injection of blinded inclisiran or placebo on Day 270, unless there is a need for discontinuing inclisiran/placebo in the course of the study
Allocation
Randomized
Enrollment
1760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inclisiran sodium 300 mg s.c. + open label rosuvastatin
Arm Type
Experimental
Arm Description
Participants will be randomized at the baseline visit (Day 1) to one of the following two double-blind treatment groups in a 1:1 ratio. Inclisiran sodium 300 mg s.c. Corresponding placebo Open label study treatment rosuvastatin: all participants will receive rosuvastatin, starting at the lowest indicated dose and titrating up until they reach their individual LDL-C target or MTD, whichever occurs first.
Arm Title
Corresponding placebo + open label rosuvastatin
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized at the baseline visit (Day 1) to one of the following two double-blind treatment groups in a 1:1 ratio. Inclisiran sodium 300 mg s.c. Corresponding placebo Open label study treatment rosuvastatin: all participants will receive rosuvastatin, starting at the lowest indicated dose and titrating up until they reach their individual LDL-C target or MTD, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Inclisiran Sodium
Other Intervention Name(s)
KJX839
Intervention Description
Subcutaneously injected on Day 1, Day 90, and Day 270
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to inclisiran 300 mg subcutaneously
Primary Outcome Measure Information:
Title
Proportion of participants achieving individual LDL-C target (<55 mg/dL or <70 mg/dL)
Description
Inclisiran on top of ongoing individually optimized lipid-lowering therapy (LLT) compared to placebo on top of ongoing individually optimized LLT on reaching a participant's individual LDL-C target as measured by the proportion of participants achieving individual LDL-C target (<55mg/dL or < 70 mg/dL) at day 90.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Relative percentage change from baseline to mean LDL-C level over the double-blind treatment period
Description
Inclisiran on top of ongoing individually optimized LLT compared to placebo on top of ongoing individualized LLT on: reducing mean LDL-C levels over the double-blind study period.
Time Frame
Baseline to Day 360
Title
Proportion of participants experiencing at least one Muscle-related adverse event (AE) as defined in the Standardized MedDRA Queries (SMQ)
Description
Participants experiencing at least one muscle-related AE as defined in the SMQ rhabdomyolysis/myopathy from day 1 to day 360.
Time Frame
Baseline to Day 360
Title
Proportion of participants experiencing self-reported pain
Description
Annualized number of days pain is experienced using pain diary
Time Frame
Baseline to Day 360
Title
Change from baseline in Short-Form Brief Pain Inventory (SF-BPI) pain severity score to Day 360
Description
Pain-related quality of life at day 360 using the SF-BPI
Time Frame
Baseline to Day 360
Title
Change from baseline in Short-Form Brief Pain Inventory (SF-BPI) pain interference score at Day 360
Description
Pain related quality of life at day 360 using the SF-BPI
Time Frame
Baseline to day 360
Title
Proportion of participants with clinically relevant change in Short-Form Brief Pain Inventory (SF-BPI) pain severity score from baseline to day 360.
Description
Pain-related quality of life at day 360 using the SF-BPI
Time Frame
Baseline to Day 360
Title
Proportion of participants with clinically relevant change in Short-Form Brief Pain Inventory (SF-BPI) pain interference score from baseline to day 360
Description
Pain-related quality of life at day 360 using the SF-BPI
Time Frame
Baseline to Day 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: Written informed consent must be obtained before any assessment is performed. Male or female participants ≥18 years of age. Participants categorized as very high or high CV risk, as defined below: •Very high risk participants with at least one of the following: A. Documented Atherosclerotic Cardiovascular Disease (ASCVD) i) Acute Coronary Syndrome: Unstable angina or myocardial infarction ii) Stable angina iii) Unequivocally documented ASCVD upon prior imaging v) Stroke and Transient Ischaemic Attack (TIA) vi) Peripheral Artery Disease (PAD) B. Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major risk factors, or early onset of Type 1 DM of long duration (> 20 years) C. A calculated SCORE2 ≥ 7.5% for age < 50 years; SCORE2 ≥ 10% for age 50-69 years; SCORE2-OP ≥ 15% for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD D. Pre-existing diagnosis of heterozygous familial hypercholesterolemia (HeFH) with ASCVD or with another major risk factor. OR •High risk participants with at least one of the following: A. Markedly elevated single risk factors, in particular total cholesterol > 310 mg/dL, LDL-C > 190 mg/dL, or blood pressure ≥ 180/110 mmHg B. Pre-existing diagnosis of HeFH without other major risk factors C. DM without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration ≥ 10 years or other additional risk factor D. Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2) E. A calculated SCORE2 2.5 to <7.5% for age under 50 years; SCORE2 5 to <10% for age 50-69 years; SCORE2-OP 7.5 to <15% for age ≥70 years to estimate 10-year risk of fatal and non-fatal CVD as defined by the cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020) LDL-C levels: in participants with very high cardiovascular risk: serum LDL-C ≥55 mg/dL in participants with high cardiovascular risk: serum LDL-C ≥70 mg/dL Participant on a stable dose of a statin for ≥ 30 days. Up to approximately 20% of total participants can be on a stable dose (for ≥ 30 days prior to screening) of another LLT on top of statin such as a cholesterol absorbing inhibitor or a bile acid sequestrant, or alternatively, an adenosine triphosphate citrate lyase (ACL) inhibitor, as indicated. Fasting triglyceride < 400 mg/dL. At Baseline: Fasting triglyceride < 400 mg/dL. Before randomization, despite being treated with the individual MTD of a statin for ≥ 30 days and, if applicable, with another LLT on top of statin (stable for ≥ 30 days), in participants with very high cardiovascular risk: serum LDL-C ≥ 55mg/dL. in participants with high cardiovascular risk: serum LDL-C ≥ 70mg/dL. Key Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 2 years at screening or baseline visit. Participants on more than one other lipid-lowering drug on top of statin at screening visit. Pre-existing diagnosis of homozygous familial hypercholesterolemia at screening or baseline visit. Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome at screening or baseline visit. Previous (within 90 days of screening), current or planned treatment with a monoclonal antibody (mAb) directed towards PCSK9 (e.g. evolocumab, alirocumab) at screening or baseline visit. Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within 2 years prior to screening or baseline visit. Previous, current or planned treatment with LDL-apheresis at screening or baseline visit. Participants with known intolerance to rosuvastatin at screening or baseline visit. History of hypersensitivity to any of the study treatments, inclisiran or rosuvastatin, or its excipients or to drugs of similar chemical classes at screening or baseline visit. Participants taking gemfibrozil at screening or baseline visit. Liver and CK: (a) Active liver disease defined as any current infectious, neoplastic, or metabolic pathology of the liver or (b) unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation > 2x ULN (except for participants with Gilbert's syndrome), or (c) creatine kinase (CK) >5x ULN at screening or baseline visit. Participant with severe renal impairment defined by eGFR <30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at screening or baseline visit. Acute coronary syndrome, ischemic stroke or TIA, coronary revascularization or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 3 months prior to the screening or baseline visit. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization within the study duration. Heart failure New York Heart Association (NYHA) class IV at screening or baseline visit. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy (excluding systemic adjuvant therapies given to prevent cancer recurrence eg: hormonotherapy for prostate or breast cancer) during the 3 years prior to screening or baseline visit. Participant with myopathy at screening or baseline visit. Participant receiving concomitant ciclosporin at screening or baseline visit. Participants that are predisposed to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose-malabsorption. Unwillingness or inability (e.g. physical or cognitive) to comply with study procedures (including study visits, fasting blood draws and compliance with study treatment regimens), and medication administration (injections) and schedule. Participant should be able and willing to read, understand and answer questionnaires. Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study at screening or baseline visit. Use of other investigational drugs within 5 half-lives, 30 days or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer or longer if required by local regulation, prior to screening visit. Pregnant or nursing (lactating) women at screening or baseline visit. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment, which includes rosuvastatin, and for 5 days (= 5 times the terminal half-life of rosuvastatin) after stopping medication. Highly effective contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms). Women are considered not of child bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessments and she is considered not of child bearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the local ICF.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Facility Information:
Facility Name
Novartis Investigative Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Liberec V Kristianova
State/Province
Czech Republic
ZIP/Postal Code
460 05
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Pardubice
State/Province
Czech Republic
ZIP/Postal Code
532 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Trutnov
State/Province
CZE
ZIP/Postal Code
46063
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Prerov
State/Province
Olomoucky Kraj
ZIP/Postal Code
750 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chlumec nad Cidlinou
ZIP/Postal Code
50351
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hlucin
ZIP/Postal Code
748 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hodonin
ZIP/Postal Code
69501
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Melnik
ZIP/Postal Code
27601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Slany
ZIP/Postal Code
27401
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Parnu
ZIP/Postal Code
80018
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Angers Cedex 01
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chambéry cedex
ZIP/Postal Code
73011
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris 13
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
St Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68305
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Winsen
State/Province
Lower Saxony
ZIP/Postal Code
21423
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30449
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kaiserslautern
State/Province
Rhineland-Palatinate
ZIP/Postal Code
67655
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Gottleuba
State/Province
Sachsen
ZIP/Postal Code
01816
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01099
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Schleswig
State/Province
Schleswig-Holstein
ZIP/Postal Code
24837
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
D 10559
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Blankenhain
ZIP/Postal Code
99444
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dessau-Roßlau
ZIP/Postal Code
06846
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erfurt
ZIP/Postal Code
99097
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45277
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45355
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45359
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gladbeck
ZIP/Postal Code
45968
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hassloch
ZIP/Postal Code
67454
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hoyerswerda
ZIP/Postal Code
02977
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koeln-Nippes
ZIP/Postal Code
50733
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
51069
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koln
ZIP/Postal Code
D-51065
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Langen
ZIP/Postal Code
63225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lichtenfels
ZIP/Postal Code
96215
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Loehne
ZIP/Postal Code
32584
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muehldorf
ZIP/Postal Code
84453
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Nuremberg
ZIP/Postal Code
90402
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Papenburg
ZIP/Postal Code
26871
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Ingbert - Oberwuerzbach
ZIP/Postal Code
66386
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singen
ZIP/Postal Code
78224
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70378
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wallerfing
ZIP/Postal Code
94574
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Warendorf
ZIP/Postal Code
48231
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Balvi
State/Province
LVA
ZIP/Postal Code
4501
Country
Latvia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ogre
ZIP/Postal Code
5001
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
1012
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1012
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krakow
State/Province
Maloposkie
ZIP/Postal Code
31271
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-528
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kielce
ZIP/Postal Code
25-020
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31 216
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rzeszow
ZIP/Postal Code
35 055
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sanlucar de Barrameda
State/Province
Andalucia
ZIP/Postal Code
11540
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

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