Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S05167
|
Drug: Atorvastatin/Perindopril
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.
|
| Active Comparator: Lipitor®
|
Drug: Atorvastatin
1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
|
| Active Comparator: Coversyl®
|
Drug: Perindopril
1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- Diastolic blood pressure (DBP) [Over 8 weeks]
Mean change from baseline in diastolic blood pressure (DBP) in each 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
- 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)
- 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%
- Adverse events and Serious adverse events (SAE) [Over 8 weeks]
Emergent Adverse events and Serious adverse events (SAE)
- Vital signs [Over 8 weeks]
Blood pressure (BP)
- Vital signs [Over 8 weeks]
Pulse rate (PR)
- 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
Eligibility Criteria
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:
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Unlikely to cooperate in the study,
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Pregnant and lactating women,
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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,
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LTD "Clinic-LJ" | Kutaisi | Georgia | 46000 | |
| 2 | LTD "Marnecore" | Marneuli | Georgia | 3000 | |
| 3 | "Aleksandre Aladashvili Clinic" LLC | Tbilisi | Georgia | 01102 | |
| 4 | Israel-Georgian Medical Research Clinic "Helsicore" | Tbilisi | Georgia | 01112 | |
| 5 | Bokhua Memorial Cardiovascular Center | Tbilisi | Georgia | 0159 | |
| 6 | Ltd "Digomi Medical Center" | Tbilisi | Georgia | 0159 | |
| 7 | LTD "MediClubGeorgia" | Tbilisi | Georgia | 0160 | |
| 8 | Emergency Cardiology Center n.a. Acad G Chapidze | Tbilisi | Georgia | 0179 | |
| 9 | FSI "Northern Medical Clinical Centre n.a. N.A. Semashko FMBA of Russia" | Arkhangel'sk | Russian Federation | 163000 | |
| 10 | Сity clinical hospital #1 named after E.E.Volosevich | Arkhangel'sk | Russian Federation | 163001 | |
| 11 | Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open joint-stock company "Russian Railways" | Chelyabinsk | Russian Federation | 454092 | |
| 12 | Federal State Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Healthcare of the Russian Federation | Moscow | Russian Federation | 101990 | |
| 13 | State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital #51" of Department of Healthcare of Moscow | Moscow | Russian Federation | 121309 | |
| 14 | "Orenburg State Medical University" based on Municipal State healthcare Institution "City Hospital emergency # 1" of the city of Orenburg | Orenburg | Russian Federation | 460040 | |
| 15 | SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko" | Penza | Russian Federation | 440026 | |
| 16 | State budgetary institution "Ryazan' regional clinical hospital" | Ryazan' | Russian Federation | 390039 | |
| 17 | Saint Petersburg state budgetary institution of healthcare "City policlinic #109" | Saint Petersburg | Russian Federation | 192289 | |
| 18 | GBOU VPO "North-Western State Medical University named after I.I. Mechnikov" , the department faculty and hospital care, court number 5 | Saint Petersburg | Russian Federation | 195067 | |
| 19 | Medical Research Institute, LLC | Saint Petersburg | Russian Federation | 196084 | |
| 20 | SPB SBHI "City Hospital # 38 n.a. N.A. Semashko" | Saint Petersburg | Russian Federation | 196600 | |
| 21 | Saint-Petersburg GUZ "City Hospital #40 of the Resort District" | Saint Petersburg | Russian Federation | 197706 | |
| 22 | St. Petersburg State Institution of Health "City Hospital № 15" Cardiology Care Unit | Saint Petersburg | Russian Federation | 198205 | |
| 23 | St. Petersburg State Budgetary Institution of Healthcare "Diagnostic center #85" | Saint Petersburg | Russian Federation | 198260 | |
| 24 | SPB SBHI "Pokrovskaya City Hospital" | Saint Petersburg | Russian Federation | 199106 | |
| 25 | Saratov Research Cardiology Institute of Roszdrav | Saratov | Russian Federation | 410028 | |
| 26 | State Budgetary institutionof heath of Tver region "Region clinical hospital" | Tver | Russian Federation | 166036 | |
| 27 | State Institution of Healthcare Vladimir region ''City Hospital № 4 of Vladimir " | Vladimir | Russian Federation | 600020 | |
| 28 | State Budgetary institution of heath of Yaroslavl region "Regional clinical hospital" | Yaroslavl | Russian Federation | 150062 | |
| 29 | 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-Frankivs'k | Ukraine | 76018 | |
| 30 | vano-Frankivsk central city clinical hospital, Cardiology department | Ivano-Frankivs'k | Ukraine | ||
| 31 | "L.T. Malaya Therapy National Institute of the National Institute of Medical Science of Ukraine" Department of aging and prevention of metabolic-associated diseases | Kharkiv | Ukraine | ||
| 32 | Kharkiv Railway Clinical Hospital #1 of Branch "Health Center" of Public Joint Stock Company "Ukrainian Railway". Cardiology Department #1 | Kharkiv | Ukraine | ||
| 33 | The Training and Research Medical Complex "The University Clinic" of the Kharkiv National Medical University, Department of Therapy, National Pharmaceutical University, Chair of Pharmacotherapy | Kharkiv | Ukraine | ||
| 34 | State Institution "Institute of gerontology named after D.F. Chebotaryov НAMS of Ukraine, Department of Clinical and Epidemiological Cardiology | Kiev | Ukraine | 04114 | |
| 35 | Medical center ''CONSILIUM MEDICAL'' | Kyiv | Ukraine | ||
| 36 | Danylo Halytskyi Lviv National Medical University Department of Therapy No. 1 and Medical Diagnostics of the Faculty of Postgraduate Education | Lviv | Ukraine | 79059 | |
| 37 | 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. | Lviv | Ukraine | ||
| 38 | The Medical and Diagnostic Center of LLC "House of Medicine" | Odesa | Ukraine | ||
| 39 | 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", | Ternopil' | Ukraine | ||
| 40 | 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 | Ternopil' | Ukraine | ||
| 41 | Municipal Non-profit Institution "Vinnytsya City Clinical Hospital #1", Therapeutical department; National Pirogov Memorial University, Vinnytsya, Chair of Propedeutics of Internal Medicine; | Vinnytsya | Ukraine | ||
| 42 | Private Small-Scale Enterprise Medical Center "Pulse" | Vinnytsya | Ukraine |
Sponsors and Collaborators
- Institut de Recherches Internationales Servier
- ADIR, a Servier Group company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CL3-05167-005