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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. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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.

NCT05288400•Servier

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Selection criteria:
•Men or women of any ethnic origin ≥18 years old who signed Informed consent form.
•Patients with uncontrolled hypertension defined by SBP ≥140 and \< 160 mmHg and DBP ≥90 and \< 100 mmHg already treated by anti-hypertensive monotherapy at maximal dose or either by a dual therapy at minimum dose, other than study treatment (amlodipine or bisoprolol or perindopril), for at least 4 weeks.
•Women of potential childbearing and men (and/or their partners) must agree to use appropriate contraceptive measures. This applies since signing of the Informed Consent form until the last study drug administration.
•Willing to provide signed and dated informed consent.
•Non selection criteria
•Unlikely to co-operate in the study, to comply with study treatment or with the study visits.
•Pregnancy, breastfeeding.
•Current participation in another randomized study or within the preceding 3 months.
•Participant already enrolled in the study.
+56 more criteria

Exclusion Criteria

•Patients whose BP was still uncontrolled at two consecutive visits (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) or whose SBP/DBP was above 160/100 mmHg (confirmed with 2 consecutive visits starting W004, at least 14 days apart).
•Onset of an adverse event (AE) which required prescription of a treatment incompatible with the protocol.
•Onset of an AE which, according to the investigator, makes it unsafe for the patient to continue with the study treatment. This includes clinically significant abnormal biochemical and haematological parameters, or clinically significant ECG abnormality.
•Pregnancy.
•Major protocol deviation preventing the analysis of the main endpoint, or which, in the opinion of the investigator, makes it unsafe for the patient to continue to take the study medication and to stay in the study.
•Non-medical reason (patient's personal decision to stop treatment).

Locations (15)

Regional state budget health care institution "Altai Regional Cardiological dispensary" 46 Malakhova St.

Barnaul, Altayskiy Kray, Russia

Problems of Cardiovascular Diseases" 6 Sosnovy Bulvar St.

Kemerovo, Russia

Autonomous non-profit organization "Medical Center "Alliance" 12 Molodezhnaya St., 12

Kirovsk, Russia

State budgetary healthcare institution of city of Moscow "City polyclinic #2 of Healthcare Department of city of Moscow" 12 Fruktovaya St.

Moscow, Russia

Federal State Budgetary Institution ''Ourpatient clinic #5'' of the Administration of the President of the Russian Federation 14 Plyushchikha St.

Moscow, Russia

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, Russia

Pavlov First Saint Petersburg State Medical University L'va Tolstogo str. 6-8

Saint Pertersburg, Russia

LLC "Medicinskie tekhnologii", Nevzorova street, 6/191025, Saint-Petersburg, Vosstania street, 8 lit A

Saint Petersburg, Russia

LLC "Strategicheskie Medicinskie Sistemy", Nevzorova street, 6

Saint Petersburg, Russia

Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic №109" 8 bld. 2 Oleko Dundicha

Saint Petersburg, Russia

Key Dates

Start Date

May 14, 2018

Primary Completion Date

December 18, 2018

Completion Date

December 18, 2018

Last Updated

June 5, 2025

Enrollment

150

ACTUAL participants

Conditions

Essential Hypertension

Interventions

Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg

COMBINATION_PRODUCT

Norvasc 5mg tablet

DRUG

Concor 5mg tablet

DRUG

Coversyl 5mg tablet

DRUG

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Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

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PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NIFEDIPINE 30MG EXTENDED-RELEASE IN ADULT PATIENTS DIAGNOSED WITH MILD OR MODERATE HYPERTENSION IN COLOMBIA.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

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PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NIFEDIPINE 30MG EXTENDED-RELEASE IN ADULT PATIENTS DIAGNOSED WITH MILD OR MODERATE HYPERTENSION IN COLOMBIA.

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