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

NCT06487949 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-07-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

valsartan-amlodipine 80/5 mg FDC

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

DRUG

valsartan 80 mg and amlodipine 5 mg as free combination

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

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-10-01
Completion
2023-12-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487949 on ClinicalTrials.gov