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

NCT06487949 | Completed Phase 4 DMC

• 1 other identifier: IR.SUMS.MED.REC.1400.505
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

hypertension; 24 hours ambulatory blood pressure monitoring; fix dose combination

Outcome Measures

Primary Outcomes (3)

• Mean 24 hours systolic blood pressure

  The average systolic blood pressure over 24 hours, during the day and at night

  8 weeks

• Mean 24 hours diastolic blood pressure

  The average diastolic blood pressure over 24 hours, during the day and at night

  8 weeks

• Mean 24 hours mean blood pressure

  The average mean blood pressure over 24 hours, during the day and at night

  8 weeks

Secondary Outcomes (1)

• Dipping

  8 weeks

Study Arms (2)

valsartan- Amlodipine fix dose combination pill

EXPERIMENTAL

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

Drug: valsartan-amlodipine 80/5 mg FDC

Valsartan- Amlodipine free dose combination

ACTIVE COMPARATOR

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

Interventions

valsartan-amlodipine 80/5 mg FDC DRUG

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

Also known as: FDC

valsartan- Amlodipine fix dose combination pill

valsartan 80 mg and amlodipine 5 mg as free combination DRUG

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

Also known as: free drug combination

Valsartan- Amlodipine free dose combination

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, 713481433, Iran

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination; Valsartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)