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

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Servier Protocol Code: CL3-05167-005 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04591808

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 43 locations

Study description

This study was done to test the combination of 2 drugs – atorvastatin and perindopril in a single capsule (called S05167) in patients with high blood pressure and dyslipidaemia.

High blood pressure is a common health condition that may cause or increase the risk of health problems. Doctors make the diagnosis by measuring blood pressure. When blood pressure is measured, two values are recorded. The higher value is called systolic blood pressure (SBP). The lower value is called diastolic blood pressure (DBP). Blood pressure is written as SBP/DBP. For example, 120/80 mmHg (millimetres of mercury).

Dyslipidaemia is a condition in some of the lipids (fats) in the blood are too high. Doctors make the diagnosis by measuring lipids such as cholesterol in the blood.

Patients need different drugs to treat their high blood pressure and high cholesterol. When this happens, patients may forget to take one of them or may dislike taking several pills. For these reasons, the researchers have developed the study drug which contains both treatments in one capsule.

The study drug is a capsule containing 2 drugs: atorvastatin and perindopril. Both these drugs are already approved and marketed.

Perindopril lowers the blood pressure by widening the blood vessels. This makes it easier for the heart to pump the blood through them.

Atorvastatin lowers the cholesterol in the blood by blocking a step in the production of cholesterol in the body.

The main goals of this study were to test:

  • If S05167 works better than atorvastatin alone in lowering high systolic blood pressure (SBP).
  • If S05167 works better than perindopril alone in lowering cholesterol levels.
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
Conditions
Dyslipidemias Hypertension
Interventions / Treatments
  • Atorvastatin/Perindopril
  • Atorvastatin
  • Perindopril
Other study id numbers
  • CL3-05167-005

Eligibility Criteria

Eligible age for the study

18 years to 79 years (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be 18 to 79 years old.
  • Have high blood pressure (either of the below):
    • For participants who were already on medication for high blood pressure:
      • The SBP was between 140 and 160 mmHg.
      • The DBP was between 90 and 100 mmHg.

or

    • For participants who had not taken any medication for high blood pressure:
      • The SBP was between 150 and 160 mmHg.
      • The DBP was between 90 and 100 mmHg.
  • Have high cholesterol levels: LDL (low-density lipoprotein) cholesterol (called “bad” cholesterol) between 110 milligrams (mg) per deciliter (mg/dL) and 190 mg/dL.

 

Participants could not take part in the study if they:

  • Were taking more than one drug for high blood pressure or to lower fat levels in the body.
  • Had liver or kidney disease.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: S05167
Intervention / Treatment
Drug: Atorvastatin/Perindopril

Participants received S05167 (one single capsule of a combination of atorvastatin 40 mg and perindopril 10 mg) orally once daily for 8 weeks.

Participant Group / Arm
Active Comparator: Lipitor®
Intervention / Treatment
Drug: Atorvastatin

Participants received Atorvastatin as a capsule at a dose of 40 mg orally once daily for 8 weeks.

Participant Group / Arm
Active Comparator: Coversyl®
Intervention / Treatment
Drug: Perindopril

Participants received Perindopril as a capsule at a dose of 10 mg orally once daily for 8 weeks.

Keywords

Provided by Servier
Dyslipidemia Hypertension Cardiovascular Atorvastatin Perindopril HMG-CoA reductase inhibitor ACE inhibitor Fixed combination
Additional Relevant MeSH Terms Glioma
Dyslipidemias Hypertension