Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.
- Conditions
- Essential Hypertension
- Interventions
- Combination Product: Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg
- Registration Number
- NCT05288400
- Lead Sponsor
- Servier
- Brief Summary
The purpose of this study was to evaluate the efficacy and the safety of a fixed-dose combination in capsule of Amlodipine 5mg/ Bisoprolol fumarate 5mg/ Perindopril arginine 5mg, and free monotherapy at the same dose in patients with uncontrolled essential hypertension.
- Detailed Description
This was a phase III, multicenter, randomized, open-label, controlled study, over a 12-week treatment period with a single-capsule of fixed dose combination (FDC) of Amlodipine 5 mg/ Bisoprolol fumarate 5 mg / Perindopril arginine 5 mg and free monocomponents of Amlodipine 5 mg, Bisoprolol fumarate 5 mg and Perindopril arginine 5 mg given concomitantly, in 150 patients with uncontrolled essential HT.
Patients without any non-selection criteria, already treated by anti-hypertensive monotherapy at maximal dose or either by a dual therapy at minimum dose, other than study treatment, having an uncontrolled HT defined by SBP (Systolic Blood Pressure) ≥ 140 and \<160 mmHg and DBP (Diastolic Blood Pressure) ≥ 90 and \<100 mmHg (in supine position) at 2 different visits (selection and inclusion) were to be selected in this study and randomized to one of two treatment groups: single-capsule combination or free therapy without any wash-out period.
For all patients, controlled blood pressure (BP) was defined as SBP \< 140 mmHg and DBP \< 90 mmHg.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg single-capsule of fixed dosed combination (FDC) of amlodipine 5 mg / bisoprolol fumarate 5 mg / perindopril arginine 5 mg Group B Norvasc 5mg tablet Free triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly Group B Concor 5mg tablet Free triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly Group B Coversyl 5mg tablet Free triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly
- Primary Outcome Measures
Name Time Method Change from baseline of blood pressure (SBP and DBP) at baseline, 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method Assessment of patient treatment satisfaction TSQM-9 questionnaire 12 weeks Blood pressure control rate (SBP < 140 mmHg and DBP < 90 mmHg) at 4, 8 and 12 weeks Response rate for antihypertensive therapy at 4, 8 and 12 weeks Rate of patients with supine blood pressure normalized (SBP \<140 mmHg and DBP \<90 mmHg) or decrease of SBP ≥20 mmHg and/or decrease of DBP ≥10 mmHg from baseline
Trial Locations
- Locations (15)
Problems of Cardiovascular Diseases" 6 Sosnovy Bulvar St.
🇷🇺Kemerovo, Russian Federation
Autonomous non-profit organization "Medical Center "Alliance" 12 Molodezhnaya St., 12
🇷🇺Kirovsk, Russian Federation
Regional state budget health care institution "Altai Regional Cardiological dispensary" 46 Malakhova St.
🇷🇺Barnaul, Altai Region, Russian Federation
St. Petersburg State Budgetary Healthcare Institution "The city hospital No.38. named after N.A. Semashko" 7/2 letter A Gospitalnaya Str., Pushkin
🇷🇺Saint Pertersburg, Russian Federation
LLC "Medicinskie tekhnologii", Nevzorova street, 6/191025, Saint-Petersburg, Vosstania street, 8 lit A
🇷🇺Saint Petersburg, Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic №109" 8 bld. 2 Oleko Dundicha
🇷🇺Saint Petersburg, Russian Federation
State budgetary healthcare institution of city of Moscow "City polyclinic #2 of Healthcare Department of city of Moscow" 12 Fruktovaya St.
🇷🇺Moscow, Russian Federation
Federal State Budgetary Institution ''Ourpatient clinic #5'' of the Administration of the President of the Russian Federation 14 Plyushchikha St.
🇷🇺Moscow, Russian Federation
Pavlov First Saint Petersburg State Medical University L'va Tolstogo str. 6-8
🇷🇺Saint Pertersburg, Russian Federation
Federal State Budgetary Institution "North-West Federal Medical Research Center n.a. V.A. Almazov" of the Ministry of Health of the Russian Federation 2 Akkuratova St.
🇷🇺Saint Petersburg, Russian Federation
LLC "Strategicheskie Medicinskie Sistemy", Nevzorova street, 6
🇷🇺Saint Petersburg, Russian Federation
Limited Liability Company "MART" 54 bld. 3 Let. J Maly Prospekt V.O
🇷🇺Saint Petersburg, Russian Federation
The Federal State Budgetary Institute "The Nikiforov Russian Center of Emergency and Radiation Medicine" The Ministry of Russian Federation for Civil Defense, Emergencies and Elimination of Consequences of Natural Disasters
🇷🇺Saint Petersburg, Russian Federation
St. Petersburg State Budgetary Healthcare Institution "City Consulting and Diagnostic Center No. 85" 89 bld. 3 Let. A Prospekt Veteranov
🇷🇺Saint-Petersburg, Russian Federation
Limited Liability Company "Medical Research Institute" 25 Let. A 3 Kolya Tomchak St.
🇷🇺Saint Petersburg, Russian Federation