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

Phase 3

Terminated

• Conditions: Dyslipidemias; Hypertension
• Interventions: Drug: Atorvastatin/Perindopril; Drug: Atorvastatin; Drug: Perindopril

• Registration Number: NCT04591808
• Lead Sponsor: Institut de Recherches Internationales Servier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-19
• Study Start: 2021-09-09
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 146

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,

3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S05167	Atorvastatin/Perindopril	-
Lipitor®	Atorvastatin	-
Coversyl®	Perindopril	-

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (SBP)	Over 8 weeks	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)	Over 8 weeks	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

Name	Time	Method
Blood pressure response	Over 8 weeks	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)
Systolic blood pressure (SBP)	Over 8 weeks	Mean change from baseline in sitting systolic blood pressure (SBP) in the S05167 group as compared with Coversyl group
Diastolic blood pressure (DBP)	Over 8 weeks	Mean change from baseline in diastolic blood pressure (DBP) in each group
Blood pressure control	Over 8 weeks	Percent of blood pressure control: BP\< 140/80 mm Hg AND % of blood pressure control: BP \< 130/80 mm Hg
Lipids control	Over 8 weeks	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%
Density Lipoprotein Cholesterol (LDLc)	Over 8 weeks	Percent of change from baseline in Low-Density Lipoprotein Cholesterol (LDLc) level in the S05167 group as compared with the Lipitor group
Pulse Pressure	Over 8 weeks	Mean change from baseline Pulse Pressure in each group
Lipid parameters	Over 8 weeks	Percent of Change from baseline
Adverse events and Serious adverse events (SAE)	Over 8 weeks	Emergent Adverse events and Serious adverse events (SAE)
Vital signs	Over 8 weeks	Respiratory rate (RR)
Electrocardiogram	Over 8 weeks	Significant abnormalities observed from ECG
Clinical lab tests	Over 8 weeks	Relevant deviations of laboratory test results

Trial Locations

Locations (43)

LTD "Clinic-LJ"; 🇬🇪 Kutaisi, Georgia

LTD "Marnecore"; 🇬🇪 Marneuli, Georgia

"Aleksandre Aladashvili Clinic" LLC; 🇬🇪 Tbilisi, Georgia

Israel-Georgian Medical Research Clinic "Helsicore"; 🇬🇪 Tbilisi, Georgia

Bokhua Memorial Cardiovascular Center; 🇬🇪 Tbilisi, Georgia

Ltd "Digomi Medical Center"; 🇬🇪 Tbilisi, Georgia

LTD "MediClubGeorgia"; 🇬🇪 Tbilisi, Georgia

Emergency Cardiology Center n.a. Acad G Chapidze; 🇬🇪 Tbilisi, Georgia

FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia"; 🇷🇺 Arkhangel'sk, Russian Federation

Сity clinical hospital #1 named after E.E.Volosevich; 🇷🇺 Arkhangel'sk, Russian Federation

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