Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy

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

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-01

Brief Summary

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

Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.

Related Clinical Trials

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

Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

NCT00699192

Hypertension

COMPLETED PHASE3

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

NCT00413049

Hypertension

COMPLETED PHASE3

Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

NCT00351130

Hypertension

COMPLETED PHASE4

Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

NCT00333489

Hypertension

COMPLETED PHASE4

A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

NCT01241487

Primary Hypertension

COMPLETED PHASE4

Detailed Description

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

Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \> 80 mmHg), and required the initiation of antihypertensive medications.

This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.

Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.

Conditions

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

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

valsartan- Amlodipine fix dose combination pill

Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill

Group Type EXPERIMENTAL

valsartan-amlodipine 80/5 mg FDC

Intervention Type DRUG

fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill

Valsartan- Amlodipine free dose combination

Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately

Group Type ACTIVE_COMPARATOR

valsartan 80 mg and amlodipine 5 mg as free combination

Intervention Type DRUG

Free combination of valsartan 80 mg and amlodipine 5 mg given separately

Interventions

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

valsartan-amlodipine 80/5 mg FDC

fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill

Intervention Type DRUG

valsartan 80 mg and amlodipine 5 mg as free combination

Free combination of valsartan 80 mg and amlodipine 5 mg given separately

Intervention Type DRUG

Other Intervention Names

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

FDC free drug combination

Eligibility Criteria

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

Inclusion Criteria

* Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure \> 130 mmHg and/or diastolic blood pressure \> 80 mmHg), and required the initiation of antihypertensive medications

Exclusion Criteria

* Patients previously been on antihypertensive drugs
* Patients had secondary high blood pressure
* Patients had severe high blood pressure (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg)
* Patients had ischemic heart disease in the past
* Patients were unable to receive any part of the treatment
* Patients who refuse to take part in study

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No