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To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

Primary Purpose

Primary Hypercholesterolemia, Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Experimental : Ezetimibe / Rosuvastatin + Telmisartan
Active comparator1 : Ezetimibe / Rosuvastatin
Active comparator2 : Telmisartan
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult male and female aged 19 to 79 years of age
  2. a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section.
  3. A person who meets the following criteria at the time of screening (visit 1)

    • MSSBP < 180mmHg and MSDBP < 110mmHg
    • LDL-C ≤ 250 mg/dL and TG < 400 mg/dL (based on organ clinical laboratory testing)
  4. A person who agrees to contraception through a medically permitted contraception method during a clinical trial period.

    • Possible pregnant female test subjects: intrauterine device (IUD) or IUS (Intrauterine system), intractorine defections, double-blocking method (complex use of blocking methods such as male condoms, female condoms, uterine cervical caps, contraceptive diaphragm, contraceptive sponges)
    • Male test subjects with potential pregnant spouses (including partners): hormonal contraception, intrauterine device (IUD) or IUS (Intrauterine system), intraperitoneal failure, double-blocking (male condom, female condom, uterine cervical cap, contraceptive diaphragm, and contraceptive blocking)
  5. Patients who have agreed in writing to voluntarily participate in this clinical trial

Randomized(Visit 2) criteria

  1. If the blood pressure measured at the time of random assignment is as follows:

    - 140mmHg ≤ MSSBP < 180mmHg and MSDBP < 110mmHg However, patients with diabetes or chronic neuropathy: 130mmHg ≤ MSSBP < 180mmHg (In the case of chronic neuropathy patients, albuinuria or proteinuria history is confirmed until the time of random assignment.)

  2. Therapeutic Lifestyle Change (TLC) after Visit 1 A person whose LDL-C and TG values correspond to the following group-specific criteria (NCEP ATP III guideline) as the basis for organ testing at the time of random assignment.

    • Group1 cardiovascular risk factor : 0~1, LDL-C(mg/dL) : 160-250, TG(mg/dL) : < 400
    • Group2 cardiovascular risk factor : 2 ≤, 10 year risk : < 10% LDL-C(mg/dL) : 160-250 TG(mg/dL) : < 400 cardiovascular risk factor : 2 ≤, 10% ≤ 10 year risk ≤ 20%, LDL-C(mg/dL) : 130-250 TG(mg/dL) : < 400
    • Group3 coronary artery disease or equivalent (20% < 10 year risk), LDL-C(mg/dL) : 100-250 TG(mg/dL) : < 400
  3. A person who does not have any inappropriate items when re-checking the selection/excluding criteria at the time of random assignment.

(except items that apply only to screening)

Exclusion Criteria:

  1. A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.)
  2. Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.)
  3. Standing low blood pressure patient with symptoms
  4. Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful.
  5. Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis.
  6. Patients with severe heart failure (NYHA class III: Symptoms due to mild exercise/classIV: Symptoms even when stabilized)
  7. A person who has one or more of the following forces within the last six months based on a screening visit (visit 1):

    • Those who have received ischemic heart disease (unstable angina, myocardial infarction), peripheral vascular disease, percutaneous coronary artery extension or coronary artery bypass treatment, etc.
    • Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, routine ischemia, etc.)
  8. A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that can affect the absorption, distribution, metabolism, and excretion of drugs.
  9. Patients with gastrointestinal diseases such as active gastritis or duodenal ulcer within one year of screening
  10. A person who has a history of muscle toxicity to fibromyalgia, myopathy, rhabdomyolysis, history of hereditary muscle disease or family history, and past HMGCoA reducing enzyme inhibitor or fibrate-related drugs.
  11. Patients with parathyroidism
  12. Patients with shock
  13. Patients with biliary obstruction or bile congestion
  14. Patients with hereditary vascular edema
  15. Patients with a history of vascular edema during ACE inhibitor or Angiotensin II receptor antagonist treatment.
  16. Patients with chronic inflammatory diseases who need continuous anti-inflammatory treatment
  17. Patients with autoimmune diseases, connective tissue diseases
  18. Those who have a history of moderate degree or malignant retinopathy (i.e., retinal bleeding, vision impairment, retinal micro aneurysm) within the previous six months based on a screening visit (visit 1)
  19. On the basis of a screening visit (visit 1) a person with malignancy, including leukemia and lymphoma, was evaluated as Complete Response (but not recurrent within at least two years from the screening date, or a malignant tumor that occurred within the minimum two years of the screening, is the only basal cell carcinoma or squamous skin cell carcinoma (Square).
  20. Patients who have run out of blood or sodium due to high doses of diuretics, dietary salinity, diarrhea and vomiting.
  21. The following institutional clinical laboratory test results (screening criteria) are available:

    • Patients with active liver disease and severe liver disorder (unknown continuous serum AST, elevated or serum ALT, person with AST more than three times the normal upper limit)
    • a person whose CPK (creatine phosphokinase) level is more than twice the normal upper limit.
    • Creatine clearance (CLcr) < 30mL/min or eGFR < 30ml/min/1.73m2.
    • a person with low potassium haemorrhage (less than 3.5 mmol/L) or high potassium haemorrhage (greater than 5.5 mmol/L)
    • Unregulated diabetics (HbA1c > 9.0%)
    • Unregulated thyroid dysfunction with a TSH level of 1.5 times or more than the normal upper limit
  22. In case of the following allergic and hypersensitive history:

    • someone with drug allergy-response anaphylaxis or hepatotoxicity.
    • Angiotensin II receptor blocker family drug or HMG-CoA reducing enzyme inhibitor
    • A person who has overreacted to a clinical trial drug or is hypersensitive to the composition of a clinical trial drug
    • A person who has genetic problems such as galactose intolerance, Lap lactase deficiencies, or glucose-galactose malabsorbtion.
  23. A person who is administering a prohibited drug in this clinical trial or is expected to be administered during the clinical trial period.
  24. Those who showed a difference of SBP ≥ 20 mmHg and DBP ≥10 mmHg in three consecutive measurements at least two minutes apart on each arm during a screening visit (visit 1)
  25. Patients who cannot stop anti-hypertensive drugs or lipid-control drugs that were being administered during a screening visit (visit 1) during the clinical trial period.
  26. Those who have or are suspected of drug or alcohol abuse within one year prior to the screening visit (visit 1)
  27. Pregnant or breastfeeding women
  28. A person who has received another clinical trial medication within three months of the first administration of the clinical trial medication in this clinical trial (if he/she has not administered the clinical trial medication or has participated in non-release observation research, he/she may register).
  29. A person who is deemed unfit by the tester (the physician in charge) to participate in this clinical trial

Sites / Locations

  • Daegu Catholic Univ Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental : Ezetimibe / Rosuvastatin + Telmisartan

Active comparator1 : Ezetimibe / Rosuvastatin

Active comparator2 : Telmisartan

Arm Description

Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks

Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks

Telmisartan 80mg PO, Once daily for 8 weeks

Outcomes

Primary Outcome Measures

Mean sitting systolic blood pressure (MSSBP)
MSSBP change at week 8 compared to baseline, experimental, active comparator1
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at week 8 compare to baseline, experimental, active comparator2

Secondary Outcome Measures

Mean sitting systolic blood pressure (MSSBP)
MSSBP change at week 4 compare to basline, experimental, active comparator1
Mean sitting diastolic blood pressure (MSDBP)
MSDBP change at week 4, 8 compare to baseline, experimental, active comparator1
the rate of patients who have reached their target blood pressure
The rate of patients who have reached their target blood pressure in experimental and active comparator1 at 4 or 8 weeks after administration of clinical trial medications (Average left blood pressure < 140/90mmHg, diabetic or chronic renal disease (only for patients with chronic renal disease with albu manure or proteinuria history) Average left and right blood pressure / 130/80mmHg)
Percentage of LDL-C change
Percentage of LDL-C change at week 4 compare to baseline, experimental, active comparator2
LDL-C change
LDL-C change at week 4, 8 compare to baseline, experimental, active comparator2
Achievement rate of LDL-C treatment goals
Achievement rate of LDL-C treatment goals in accordance with NCEP ATP III criteria at 4 and 8 weeks after administration of clinical trial medications, experimental, active comparator2 (Group1 : < 160mg/dL, Group 2: < 130mg/dL, Group 3: < 100mg/dL)
Percentage of lipid indicators change
Percentage of lipid indicators(TC, HDL-C, TG, LDL-C/HDL-C, TC/HDL-C, non-HDL-C, Apo B) change at week 4, 8 compare to baseline, experimental, active comparator2
Lipid indicators chage
Lipid indicators(TC, HDL-C, TG, LDL-C/HDL-C, TC/HDL-C, non-HDL-C, Apo B) change at week 4, 8 compare to baseline, experimental, active comparator2

Full Information

First Posted
December 2, 2020
Last Updated
December 2, 2020
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04659070
Brief Title
To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia
Official Title
A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
May 19, 2022 (Anticipated)
Study Completion Date
May 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in patients with essential hypertension and primary hypercholesterolemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental : Ezetimibe / Rosuvastatin + Telmisartan
Arm Type
Experimental
Arm Description
Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks
Arm Title
Active comparator1 : Ezetimibe / Rosuvastatin
Arm Type
Active Comparator
Arm Description
Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks
Arm Title
Active comparator2 : Telmisartan
Arm Type
Active Comparator
Arm Description
Telmisartan 80mg PO, Once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Experimental : Ezetimibe / Rosuvastatin + Telmisartan
Intervention Description
Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Active comparator1 : Ezetimibe / Rosuvastatin
Intervention Description
Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Active comparator2 : Telmisartan
Intervention Description
Telmisartan 80mg PO, Once daily for 8 weeks
Primary Outcome Measure Information:
Title
Mean sitting systolic blood pressure (MSSBP)
Description
MSSBP change at week 8 compared to baseline, experimental, active comparator1
Time Frame
baseline, week 8
Title
Low density lipoprotein cholesterol (LDL-C)
Description
LDL-C change at week 8 compare to baseline, experimental, active comparator2
Time Frame
baseline, week 8
Secondary Outcome Measure Information:
Title
Mean sitting systolic blood pressure (MSSBP)
Description
MSSBP change at week 4 compare to basline, experimental, active comparator1
Time Frame
baseline, week 4
Title
Mean sitting diastolic blood pressure (MSDBP)
Description
MSDBP change at week 4, 8 compare to baseline, experimental, active comparator1
Time Frame
baseline, week 4, week 8
Title
the rate of patients who have reached their target blood pressure
Description
The rate of patients who have reached their target blood pressure in experimental and active comparator1 at 4 or 8 weeks after administration of clinical trial medications (Average left blood pressure < 140/90mmHg, diabetic or chronic renal disease (only for patients with chronic renal disease with albu manure or proteinuria history) Average left and right blood pressure / 130/80mmHg)
Time Frame
week4, week8
Title
Percentage of LDL-C change
Description
Percentage of LDL-C change at week 4 compare to baseline, experimental, active comparator2
Time Frame
baseline, week4
Title
LDL-C change
Description
LDL-C change at week 4, 8 compare to baseline, experimental, active comparator2
Time Frame
baseline, week4, week8
Title
Achievement rate of LDL-C treatment goals
Description
Achievement rate of LDL-C treatment goals in accordance with NCEP ATP III criteria at 4 and 8 weeks after administration of clinical trial medications, experimental, active comparator2 (Group1 : < 160mg/dL, Group 2: < 130mg/dL, Group 3: < 100mg/dL)
Time Frame
week4, week8
Title
Percentage of lipid indicators change
Description
Percentage of lipid indicators(TC, HDL-C, TG, LDL-C/HDL-C, TC/HDL-C, non-HDL-C, Apo B) change at week 4, 8 compare to baseline, experimental, active comparator2
Time Frame
baseline, week4. week8
Title
Lipid indicators chage
Description
Lipid indicators(TC, HDL-C, TG, LDL-C/HDL-C, TC/HDL-C, non-HDL-C, Apo B) change at week 4, 8 compare to baseline, experimental, active comparator2
Time Frame
basline, week4, week8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male and female aged 19 to 79 years of age a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section. A person who meets the following criteria at the time of screening (visit 1) MSSBP < 180mmHg and MSDBP < 110mmHg LDL-C ≤ 250 mg/dL and TG < 400 mg/dL (based on organ clinical laboratory testing) A person who agrees to contraception through a medically permitted contraception method during a clinical trial period. Possible pregnant female test subjects: intrauterine device (IUD) or IUS (Intrauterine system), intractorine defections, double-blocking method (complex use of blocking methods such as male condoms, female condoms, uterine cervical caps, contraceptive diaphragm, contraceptive sponges) Male test subjects with potential pregnant spouses (including partners): hormonal contraception, intrauterine device (IUD) or IUS (Intrauterine system), intraperitoneal failure, double-blocking (male condom, female condom, uterine cervical cap, contraceptive diaphragm, and contraceptive blocking) Patients who have agreed in writing to voluntarily participate in this clinical trial Randomized(Visit 2) criteria If the blood pressure measured at the time of random assignment is as follows: - 140mmHg ≤ MSSBP < 180mmHg and MSDBP < 110mmHg However, patients with diabetes or chronic neuropathy: 130mmHg ≤ MSSBP < 180mmHg (In the case of chronic neuropathy patients, albuinuria or proteinuria history is confirmed until the time of random assignment.) Therapeutic Lifestyle Change (TLC) after Visit 1 A person whose LDL-C and TG values correspond to the following group-specific criteria (NCEP ATP III guideline) as the basis for organ testing at the time of random assignment. Group1 cardiovascular risk factor : 0~1, LDL-C(mg/dL) : 160-250, TG(mg/dL) : < 400 Group2 cardiovascular risk factor : 2 ≤, 10 year risk : < 10% LDL-C(mg/dL) : 160-250 TG(mg/dL) : < 400 cardiovascular risk factor : 2 ≤, 10% ≤ 10 year risk ≤ 20%, LDL-C(mg/dL) : 130-250 TG(mg/dL) : < 400 Group3 coronary artery disease or equivalent (20% < 10 year risk), LDL-C(mg/dL) : 100-250 TG(mg/dL) : < 400 A person who does not have any inappropriate items when re-checking the selection/excluding criteria at the time of random assignment. (except items that apply only to screening) Exclusion Criteria: A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.) Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.) Standing low blood pressure patient with symptoms Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful. Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis. Patients with severe heart failure (NYHA class III: Symptoms due to mild exercise/classIV: Symptoms even when stabilized) A person who has one or more of the following forces within the last six months based on a screening visit (visit 1): Those who have received ischemic heart disease (unstable angina, myocardial infarction), peripheral vascular disease, percutaneous coronary artery extension or coronary artery bypass treatment, etc. Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, routine ischemia, etc.) A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that can affect the absorption, distribution, metabolism, and excretion of drugs. Patients with gastrointestinal diseases such as active gastritis or duodenal ulcer within one year of screening A person who has a history of muscle toxicity to fibromyalgia, myopathy, rhabdomyolysis, history of hereditary muscle disease or family history, and past HMGCoA reducing enzyme inhibitor or fibrate-related drugs. Patients with parathyroidism Patients with shock Patients with biliary obstruction or bile congestion Patients with hereditary vascular edema Patients with a history of vascular edema during ACE inhibitor or Angiotensin II receptor antagonist treatment. Patients with chronic inflammatory diseases who need continuous anti-inflammatory treatment Patients with autoimmune diseases, connective tissue diseases Those who have a history of moderate degree or malignant retinopathy (i.e., retinal bleeding, vision impairment, retinal micro aneurysm) within the previous six months based on a screening visit (visit 1) On the basis of a screening visit (visit 1) a person with malignancy, including leukemia and lymphoma, was evaluated as Complete Response (but not recurrent within at least two years from the screening date, or a malignant tumor that occurred within the minimum two years of the screening, is the only basal cell carcinoma or squamous skin cell carcinoma (Square). Patients who have run out of blood or sodium due to high doses of diuretics, dietary salinity, diarrhea and vomiting. The following institutional clinical laboratory test results (screening criteria) are available: Patients with active liver disease and severe liver disorder (unknown continuous serum AST, elevated or serum ALT, person with AST more than three times the normal upper limit) a person whose CPK (creatine phosphokinase) level is more than twice the normal upper limit. Creatine clearance (CLcr) < 30mL/min or eGFR < 30ml/min/1.73m2. a person with low potassium haemorrhage (less than 3.5 mmol/L) or high potassium haemorrhage (greater than 5.5 mmol/L) Unregulated diabetics (HbA1c > 9.0%) Unregulated thyroid dysfunction with a TSH level of 1.5 times or more than the normal upper limit In case of the following allergic and hypersensitive history: someone with drug allergy-response anaphylaxis or hepatotoxicity. Angiotensin II receptor blocker family drug or HMG-CoA reducing enzyme inhibitor A person who has overreacted to a clinical trial drug or is hypersensitive to the composition of a clinical trial drug A person who has genetic problems such as galactose intolerance, Lap lactase deficiencies, or glucose-galactose malabsorbtion. A person who is administering a prohibited drug in this clinical trial or is expected to be administered during the clinical trial period. Those who showed a difference of SBP ≥ 20 mmHg and DBP ≥10 mmHg in three consecutive measurements at least two minutes apart on each arm during a screening visit (visit 1) Patients who cannot stop anti-hypertensive drugs or lipid-control drugs that were being administered during a screening visit (visit 1) during the clinical trial period. Those who have or are suspected of drug or alcohol abuse within one year prior to the screening visit (visit 1) Pregnant or breastfeeding women A person who has received another clinical trial medication within three months of the first administration of the clinical trial medication in this clinical trial (if he/she has not administered the clinical trial medication or has participated in non-release observation research, he/she may register). A person who is deemed unfit by the tester (the physician in charge) to participate in this clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kee Sik Kim, CI
Phone
053-650-4455
Email
kks7379@cu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Kyoung Hee Baek, PM
Phone
82-2-3489-6160
Email
khbaek@hanlim.com
Facility Information:
Facility Name
Daegu Catholic Univ Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Sik Kim, PI

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

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