Trials / Completed
CompletedNCT05288400
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.
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. A Multicentre, Randomized, Open-label, 12-weeks Study.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Servier · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg | 1 capsule/day Oral administration |
| DRUG | Norvasc 5mg tablet | Norvasc (amlodipine) 5mg, 1 tablet/day |
| DRUG | Concor 5mg tablet | Concor (bisoprolol fumarate) 5mg, 1 tablet/day |
| DRUG | Coversyl 5mg tablet | Coversyl (perindopril arginine) 5mg, 1 tablet/day |
Timeline
- Start date
- 2018-05-14
- Primary completion
- 2018-12-18
- Completion
- 2018-12-18
- First posted
- 2022-03-21
- Last updated
- 2025-06-05
Locations
15 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05288400. Inclusion in this directory is not an endorsement.