A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Irbesartan and Amlodipine Combination in Controlling Blood Pressure

NCT00950066

Hypertension

COMPLETED PHASE2

Open Label Study Telmisartan and Amlodipine in Hypertension

NCT00614380

Hypertension

COMPLETED PHASE3

Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet in Patients With Mild to Moderate Hypertension

NCT00861016

Hypertension

COMPLETED PHASE4

S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients.

NCT04457323

Hypertension

UNKNOWN PHASE4

Evaluation of the Antihypertensive effectIveness, Tolerability, and Adherence With Amlodipine/ Indapamide/ Perindopril Triple Single-pill Combination in Hypertensive Patients Without Concomitant Antihypertensive Therapy (TRIPTYCH)

NCT06259175

Arterial Hypertension HTN

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

FDC of Metoprolol XL 50mg + Amlodipine 5mg

Group Type EXPERIMENTAL

Metoprolol XL 50mg + Amlodipine 5mg

Intervention Type DRUG

tablet,oral,OD,8 weeks

2

FDC of Metoprolol XL 25mg + Amlodipine 2.5mg

Group Type EXPERIMENTAL

Metoprolol XL 25 mg + Amlodipine 2.5mg

Intervention Type DRUG

tablet,oral,OD,8 weeks

3

Extended release Metoprolol succinate

Group Type ACTIVE_COMPARATOR

Metoprolol XL 50mg

Intervention Type DRUG

tablet,oral,OD,8 weeks

4

Extended release Metoprolol succinate

Group Type ACTIVE_COMPARATOR

Metoprolol XL 25 mg

Intervention Type DRUG

tablet,oral,OD,8 weeks

5

Amlodipine 5mg in immediate release formulation

Group Type ACTIVE_COMPARATOR

Amlodipine 5mg

Intervention Type DRUG

tablet,oral,OD,8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metoprolol XL 50mg + Amlodipine 5mg

tablet,oral,OD,8 weeks

Intervention Type DRUG

Metoprolol XL 25 mg + Amlodipine 2.5mg

tablet,oral,OD,8 weeks

Intervention Type DRUG

Metoprolol XL 50mg

tablet,oral,OD,8 weeks

Intervention Type DRUG

Metoprolol XL 25 mg

tablet,oral,OD,8 weeks

Intervention Type DRUG

Amlodipine 5mg

tablet,oral,OD,8 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Selomax 50/5 Selomax 25/2.5 Revelol XL Revelol XL Amlogard

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
* Those who have given their written consent for the study.

Exclusion Criteria

* Patients of other forms of hypertension (other than primary)
* Those who have consistently BP \> /=180/120mmHg
* Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
* Patients of diabetes requiring insulin,asthma and kidney diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No