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

June 28, 2024 updated by: Javad Kojuri, Shiraz University of Medical Sciences

Comparative Analysis of Valsartan 80 mg and Amlodipine 5 mg in Fixed-Dose Combination Therapy Versus Combination Free Drug Therapy for Ambulatory Blood Pressure Management: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: valsartan- Amlodipine fix dose combination pill
Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill
Drug: valsartan-amlodipine 80/5 mg FDC
fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill
Other Names:
  • FDC
Active Comparator: Valsartan- Amlodipine free dose combination
Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately
Drug: valsartan 80 mg and amlodipine 5 mg as free combination
Free combination of valsartan 80 mg and amlodipine 5 mg given separately
Other Names:
  • free drug combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean 24 hours systolic blood pressure
Time Frame: 8 weeks
The average systolic blood pressure over 24 hours, during the day and at night
8 weeks
Mean 24 hours diastolic blood pressure
Time Frame: 8 weeks
The average diastolic blood pressure over 24 hours, during the day and at night
8 weeks
Mean 24 hours mean blood pressure
Time Frame: 8 weeks
The average mean blood pressure over 24 hours, during the day and at night
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dipping
Time Frame: 8 weeks
Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.SUMS.MED.REC.1400.505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is available based on rational request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe