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)
Regional state budget health care institution "Altai Regional Cardiological dispensary" 46 Malakhova St.
🇷🇺Barnaul, Altai Region, Russian Federation
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
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
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
Pavlov First Saint Petersburg State Medical University L'va Tolstogo str. 6-8
🇷🇺Saint Pertersburg, Russian Federation
LLC "Medicinskie tekhnologii", Nevzorova street, 6/191025, Saint-Petersburg, Vosstania street, 8 lit A
🇷🇺Saint Petersburg, Russian Federation
LLC "Strategicheskie Medicinskie Sistemy", Nevzorova street, 6
🇷🇺Saint Petersburg, Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic №109" 8 bld. 2 Oleko Dundicha
🇷🇺Saint Petersburg, Russian Federation
Scroll for more (5 remaining)Regional state budget health care institution "Altai Regional Cardiological dispensary" 46 Malakhova St.🇷🇺Barnaul, Altai Region, Russian Federation