Clinical Trials Logo
  1. Home
  2. Essential Hypertension
  3. NCT05288400

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.

Essential Hypertension Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05288400
Study type Interventional
Source Servier
Contact
Status Completed
Phase Phase 3
Start date May 14, 2018
Completion date December 18, 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03708601 - Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
Not yet recruiting NCT05503953 - Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS Phase 3
Recruiting NCT05526703 - Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy Phase 3
Completed NCT06395194 - Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension Phase 3
Not yet recruiting NCT06418074 - Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity N/A
Completed NCT02890173 - Study of CS-3150 in Patients With Essential Hypertension Phase 3
Completed NCT02944734 - Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension Phase 2
Withdrawn NCT02096939 - Microvascular Function in Primary Aldosteronism N/A
Recruiting NCT01956786 - Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine Phase 2/Phase 3
Completed NCT02553512 - Helius in Hypertension-I: The UK Hypertension Registry N/A
Completed NCT01198249 - Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension Phase 1
Completed NCT01001572 - Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension Phase 3
Recruiting NCT00380289 - Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension N/A
Completed NCT00139698 - Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension Phase 3
Completed NCT00288184 - Uric Acid in Essential Hypertension in Children Phase 2
Completed NCT01289886 - Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects Phase 1
Not yet recruiting NCT06041529 - Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension Phase 4
Completed NCT04470830 - A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
Completed NCT00758524 - A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension Phase 2
Recruiting NCT05109013 - Juvenile Essential Arterial Hypertension and Vascular Function