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Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia

Primary Purpose

Dyslipidemias, Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atorvastatin/Perindopril
Atorvastatin
Perindopril
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Dyslipidemia, Hypertension, Cardiovascular, Atorvastatin, Perindopril, HMG-CoA reductase inhibitor, ACE inhibitor, Fixed combination

Eligibility Criteria

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

Inclusion Criteria:

  1. Men or women from 18 to 79 years old who can comply with the study requirements and timetable,

  2. Patients diagnosed with Essential hypertension (as documented in patient's medical file). The diagnosis of hypertension should be based on at least two BP measurements on at least two visits.

    Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril) for combined systolic and diastolic hypertension (140 mmHg ≤ SBP < 160 mmHg and 90 mmHg ≤ DBP < 100 mmHg).

    or Hypertensive patients naïve of treatment with 150 mmHg ≤ SBP <160 mmHg and 90 mmHg ≤ DBP < 100 mmHg.

  3. Dysplipidemic patients: naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 110 mg/ Decilitre (dL) (or 2.84 millimole [mmol] /L) ≤ LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a previous laboratory result within 12 months.

Exclusion Criteria:

  1. Unlikely to cooperate in the study,
  2. Pregnant and lactating women,

4. Participation in another study at the same time or having participated in another study within 3 months before selection participation in noninterventional registries or epidemiological studies is allowed,

6.Patients treated with >1 anti-hypertensive drug or >1 Lipid lowering drug,

7.Patients previously treated with atorvastatin and/or perindopril,

8.Known resistance to ACE inhibitors,

9.Patients treated with beta-blockers or alpha-blockers,

10. Patients with liver disease or renal impairment,

11.Certain known cardiovascular diseases or cardiac rhythm disorders,

12.Known or suspected symptomatic orthostatic hypotension,

13.Familial hypercholesterolemia,

14.Secondary hypertension or dyslipidemia,

15.Patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs,

16.Hypersensitivity to any other ACE inhibitor,

17.History of angioedema associated with previous ACE inhibitor therapy.

Sites / Locations

  • LTD "Clinic-LJ"
  • LTD "Marnecore"
  • "Aleksandre Aladashvili Clinic" LLC
  • Israel-Georgian Medical Research Clinic "Helsicore"
  • Bokhua Memorial Cardiovascular Center
  • Ltd "Digomi Medical Center"
  • LTD "MediClubGeorgia"
  • Emergency Cardiology Center n.a. Acad G Chapidze
  • FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"
  • Сity clinical hospital #1 named after E.E.Volosevich
  • Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways"
  • Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
  • State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 17 of the Department of Healthcare of the City of Moscow"
  • State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow
  • "Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg
  • SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko"
  • State budgetary institution "Ryazan' regional clinical hospital"
  • Saint Petersburg state budgetary institution of healthcare "City policlinic #109"
  • GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5
  • Medical Research Institute, LLC
  • SPB SBHI "City Hospital # 38 n.a. N.A. Semashko"
  • Saint-Petersburg GUZ "City Hospital #40 of the Resort District"
  • St. Petersburg State Institution of Health "City Hospital № 15" Cardiology Care Unit
  • St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85"
  • SPB SBHI "Pokrovskaya City Hospital"
  • LLC "MART" Sankt Petersburg
  • Saratov Research Cardiology Institute of Roszdrav
  • State Budgetary institutionof heath of Tver region "Region clinical hospital"
  • State Institution of Healthcare Vladimir region ''City Hospital № 4 of Vladimir "
  • State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital"
  • State Higher Educational Institution "Ivano-Frankivsk National Medical University", Chair of Internal Medicine #2 and Nursing based on Communal Institution Ivano-Frankivsk Regional Clinical Cardiological Center, Chronic Ischaemic Heart Disease Department
  • Ivano-Frankivsk central city clinical hospital, Cardiology department
  • "L.T. Malaya Therapy National Institute of the National Institute of Medical Science of Ukraine" Department of aging and prevention of metabolic-associated diseases
  • The Training and Research Medical Complex "The University Clinic" of the Kharkiv National Medical University, Department of Therapy, National Pharmaceutical University, Chair of Pharmacotherapy
  • State Institution "Institute of gerontology named after D.F. Chebotaryov НAMS of Ukraine, Department of Clinical and Epidemiological Cardiology
  • Medical center ''CONSILIUM MEDICAL''
  • Danylo Halytskyi Lviv National Medical University Department of Therapy No. 1 and Medical Diagnostics of the Faculty of Postgraduate Education
  • Chair of Propedeutic of Internal Medicine #1 of Danylo Halytsky Lviv National Medical University based Municipal Non-profit Enterprise "Lviv City Clinical Hospital #5" Out-patient department.
  • The Medical and Diagnostic Center of LLC "House of Medicine"
  • Chair of Internal Medicine #3 of Ternopil National Medical University named after I. Gorbachevsky of MOH of Ukraine based on Outpatient Department of Municipal Institution of Ternopil Regional Council "Ternopil University Hospital",
  • Communal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council, Department of Rheumatology, I. Horbachevsky Ternopil National Medical University of MOH of Ukraine, Chair of Internal Medicine #2
  • Municipal Non-profit Institution "Vinnytsya City Clinical Hospital #1", Therapeutical department; National Pirogov Memorial University, Vinnytsya, Chair of Propedeutics of Internal Medicine;
  • Private Small-Scale Enterprise Medical Center "Pulse"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

S05167

Lipitor®

Coversyl®

Arm Description

Outcomes

Primary Outcome Measures

Systolic blood pressure (SBP)
Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with the Lipitor group (in terms of superiority)
Low-Density Lipoprotein Cholesterol (LDLc)
Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) in the S05167 group as compared with the Coversyl group (in terms of superiority)

Secondary Outcome Measures

Systolic blood pressure (SBP)
Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with Coversyl group
Density Lipoprotein Cholesterol (LDLc)
Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) level in the S05167 group as compared with the Lipitor group
Diastolic blood pressure (DBP)
Mean change from baseline in diastolic blood pressure (DBP) in each group
Pulse Pressure
Mean change from baseline Pulse Pressure in each group
Lipid parameters
Percent of Change from baseline
Blood pressure response
Percent of responders (in terms of blood pressure response defined by patients with BP< 140/90 mm Hg or SBP decrease > = 20 mm Hg or DBP decrease > =10 mm Hg)
Blood pressure control
Percent of blood pressure control: BP< 140/80 mm Hg AND % of blood pressure control: BP < 130/80 mm Hg
Lipids control
Percent of responders (in terms of lipids control: an absolute reduction to an LDLc level< 2.6 mmol/L [100 mg/dL] or a reduction at least 50%
Adverse events and Serious adverse events (SAE)
Emergent Adverse events and Serious adverse events (SAE)
Vital signs
Blood pressure (BP)
Vital signs
Pulse rate (PR)
Vital signs
Respiratory rate (RR)
Electrocardiogram
Significant abnormalities observed from ECG
Clinical lab tests
Relevant deviations of laboratory test results

Full Information

First Posted
September 30, 2020
Last Updated
October 17, 2023
Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
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1. Study Identification

Unique Protocol Identification Number
NCT04591808
Brief Title
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
Official Title
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia, 8 Weeks, Phase 3, Randomized, Double-blind, Active-control, Multinational, Multi-center, Parallel Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
for strategic reasons
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
April 8, 2022 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company

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
The purpose of this study is to demonstrate the superiority of atorvastatin/perindopril fixed dose combination (FDC) S05167 as compared to atorvastatin reference drug alone or perindopril drug alone on systolic blood pressure decrease and LDL cholesterol decrease respectively in patients presenting with hypertension and dyslipidemia after 8 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Hypertension
Keywords
Dyslipidemia, Hypertension, Cardiovascular, Atorvastatin, Perindopril, HMG-CoA reductase inhibitor, ACE inhibitor, Fixed combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S05167
Arm Type
Experimental
Arm Title
Lipitor®
Arm Type
Active Comparator
Arm Title
Coversyl®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin/Perindopril
Intervention Description
1 over-encapsulated S05167 capsule, fixed dose combination of Atorvastatin/Perindopril Arginine 40/10 mg, will be administered once daily each day before breakfast during 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Perindopril
Intervention Description
1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.
Primary Outcome Measure Information:
Title
Systolic blood pressure (SBP)
Description
Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with the Lipitor group (in terms of superiority)
Time Frame
Over 8 weeks
Title
Low-Density Lipoprotein Cholesterol (LDLc)
Description
Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) in the S05167 group as compared with the Coversyl group (in terms of superiority)
Time Frame
Over 8 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure (SBP)
Description
Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with Coversyl group
Time Frame
Over 8 weeks
Title
Density Lipoprotein Cholesterol (LDLc)
Description
Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) level in the S05167 group as compared with the Lipitor group
Time Frame
Over 8 weeks
Title
Diastolic blood pressure (DBP)
Description
Mean change from baseline in diastolic blood pressure (DBP) in each group
Time Frame
Over 8 weeks
Title
Pulse Pressure
Description
Mean change from baseline Pulse Pressure in each group
Time Frame
Over 8 weeks
Title
Lipid parameters
Description
Percent of Change from baseline
Time Frame
Over 8 weeks
Title
Blood pressure response
Description
Percent of responders (in terms of blood pressure response defined by patients with BP< 140/90 mm Hg or SBP decrease > = 20 mm Hg or DBP decrease > =10 mm Hg)
Time Frame
Over 8 weeks
Title
Blood pressure control
Description
Percent of blood pressure control: BP< 140/80 mm Hg AND % of blood pressure control: BP < 130/80 mm Hg
Time Frame
Over 8 weeks
Title
Lipids control
Description
Percent of responders (in terms of lipids control: an absolute reduction to an LDLc level< 2.6 mmol/L [100 mg/dL] or a reduction at least 50%
Time Frame
Over 8 weeks
Title
Adverse events and Serious adverse events (SAE)
Description
Emergent Adverse events and Serious adverse events (SAE)
Time Frame
Over 8 weeks
Title
Vital signs
Description
Blood pressure (BP)
Time Frame
Over 8 weeks
Title
Vital signs
Description
Pulse rate (PR)
Time Frame
Over 8 weeks
Title
Vital signs
Description
Respiratory rate (RR)
Time Frame
Over 8 weeks
Title
Electrocardiogram
Description
Significant abnormalities observed from ECG
Time Frame
Over 8 weeks
Title
Clinical lab tests
Description
Relevant deviations of laboratory test results
Time Frame
Over 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women from 18 to 79 years old who can comply with the study requirements and timetable, Patients diagnosed with Essential hypertension (as documented in patient's medical file). The diagnosis of hypertension should be based on at least two BP measurements on at least two visits. Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril) for combined systolic and diastolic hypertension (140 mmHg ≤ SBP < 160 mmHg and 90 mmHg ≤ DBP < 100 mmHg). or Hypertensive patients naïve of treatment with 150 mmHg ≤ SBP <160 mmHg and 90 mmHg ≤ DBP < 100 mmHg. Dysplipidemic patients: naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 110 mg/ Decilitre (dL) (or 2.84 millimole [mmol] /L) ≤ LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a previous laboratory result within 12 months. Exclusion Criteria: Unlikely to cooperate in the study, Pregnant and lactating women, 4. Participation in another study at the same time or having participated in another study within 3 months before selection participation in noninterventional registries or epidemiological studies is allowed, 6.Patients treated with >1 anti-hypertensive drug or >1 Lipid lowering drug, 7.Patients previously treated with atorvastatin and/or perindopril, 8.Known resistance to ACE inhibitors, 9.Patients treated with beta-blockers or alpha-blockers, 10. Patients with liver disease or renal impairment, 11.Certain known cardiovascular diseases or cardiac rhythm disorders, 12.Known or suspected symptomatic orthostatic hypotension, 13.Familial hypercholesterolemia, 14.Secondary hypertension or dyslipidemia, 15.Patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs, 16.Hypersensitivity to any other ACE inhibitor, 17.History of angioedema associated with previous ACE inhibitor therapy.
Facility Information:
Facility Name
LTD "Clinic-LJ"
City
Kutaisi
ZIP/Postal Code
46000
Country
Georgia
Facility Name
LTD "Marnecore"
City
Marneuli
ZIP/Postal Code
3000
Country
Georgia
Facility Name
"Aleksandre Aladashvili Clinic" LLC
City
Tbilisi
ZIP/Postal Code
01102
Country
Georgia
Facility Name
Israel-Georgian Medical Research Clinic "Helsicore"
City
Tbilisi
ZIP/Postal Code
01112
Country
Georgia
Facility Name
Bokhua Memorial Cardiovascular Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Ltd "Digomi Medical Center"
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD "MediClubGeorgia"
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Emergency Cardiology Center n.a. Acad G Chapidze
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"
City
Arkhangel'sk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Сity clinical hospital #1 named after E.E.Volosevich
City
Arkhangel'sk
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways"
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Facility Name
Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 17 of the Department of Healthcare of the City of Moscow"
City
Moscow
ZIP/Postal Code
120016
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
"Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg
City
Orenburg
ZIP/Postal Code
460040
Country
Russian Federation
Facility Name
SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko"
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
State budgetary institution "Ryazan' regional clinical hospital"
City
Ryazan'
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Saint Petersburg state budgetary institution of healthcare "City policlinic #109"
City
Saint Petersburg
ZIP/Postal Code
192289
Country
Russian Federation
Facility Name
GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Medical Research Institute, LLC
City
Saint Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
SPB SBHI "City Hospital # 38 n.a. N.A. Semashko"
City
Saint Petersburg
ZIP/Postal Code
196600
Country
Russian Federation
Facility Name
Saint-Petersburg GUZ "City Hospital #40 of the Resort District"
City
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
St. Petersburg State Institution of Health "City Hospital № 15" Cardiology Care Unit
City
Saint Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85"
City
Saint Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
SPB SBHI "Pokrovskaya City Hospital"
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
LLC "MART" Sankt Petersburg
City
Saint Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
Saratov Research Cardiology Institute of Roszdrav
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
State Budgetary institutionof heath of Tver region "Region clinical hospital"
City
Tver
ZIP/Postal Code
166036
Country
Russian Federation
Facility Name
State Institution of Healthcare Vladimir region ''City Hospital № 4 of Vladimir "
City
Vladimir
ZIP/Postal Code
600020
Country
Russian Federation
Facility Name
State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital"
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
State Higher Educational Institution "Ivano-Frankivsk National Medical University", Chair of Internal Medicine #2 and Nursing based on Communal Institution Ivano-Frankivsk Regional Clinical Cardiological Center, Chronic Ischaemic Heart Disease Department
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Ivano-Frankivsk central city clinical hospital, Cardiology department
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
"L.T. Malaya Therapy National Institute of the National Institute of Medical Science of Ukraine" Department of aging and prevention of metabolic-associated diseases
City
Kharkiv
Country
Ukraine
Facility Name
The Training and Research Medical Complex "The University Clinic" of the Kharkiv National Medical University, Department of Therapy, National Pharmaceutical University, Chair of Pharmacotherapy
City
Kharkiv
Country
Ukraine
Facility Name
State Institution "Institute of gerontology named after D.F. Chebotaryov НAMS of Ukraine, Department of Clinical and Epidemiological Cardiology
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Medical center ''CONSILIUM MEDICAL''
City
Kyiv
Country
Ukraine
Facility Name
Danylo Halytskyi Lviv National Medical University Department of Therapy No. 1 and Medical Diagnostics of the Faculty of Postgraduate Education
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Chair of Propedeutic of Internal Medicine #1 of Danylo Halytsky Lviv National Medical University based Municipal Non-profit Enterprise "Lviv City Clinical Hospital #5" Out-patient department.
City
Lviv
Country
Ukraine
Facility Name
The Medical and Diagnostic Center of LLC "House of Medicine"
City
Odesa
Country
Ukraine
Facility Name
Chair of Internal Medicine #3 of Ternopil National Medical University named after I. Gorbachevsky of MOH of Ukraine based on Outpatient Department of Municipal Institution of Ternopil Regional Council "Ternopil University Hospital",
City
Ternopil'
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council, Department of Rheumatology, I. Horbachevsky Ternopil National Medical University of MOH of Ukraine, Chair of Internal Medicine #2
City
Ternopil'
Country
Ukraine
Facility Name
Municipal Non-profit Institution "Vinnytsya City Clinical Hospital #1", Therapeutical department; National Pirogov Memorial University, Vinnytsya, Chair of Propedeutics of Internal Medicine;
City
Vinnytsya
Country
Ukraine
Facility Name
Private Small-Scale Enterprise Medical Center "Pulse"
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing Access Criteria
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
IPD Sharing URL
https://clinicaltrials.servier.com/
Links:
URL
https://clinicaltrials.servier.com/
Description
Find Results on Servier Clinical Trial Data website
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
[study-level clinical trial data]
Available IPD/Information URL
https://clinicaltrials.servier.com/

Learn more about this trial

Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia

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