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Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.

NCT05110898 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-03-21

No results posted yet for this study

Summary

Phase III clinical trial, multicenter of non-inferiority, randomized, single-blind evaluation of fixed-dose combination of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.

Conditions

Interventions

DRUG

fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg

Fixed-dose of Olmesartan 20mg or 40 mg + Indapamide 1,5 mg oral administration, once a day for 12 weeks. Initially, the participant will be treated with Olmesartan 20mg + Indapamide 1,5 mg. If after 6 weeks the diastolic blood pressure is above 90 mmHg, the dose will be changed to fixed dose of Olmesartan 40 mg + Indapamide 1,5 mg.

DRUG

Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)

Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) oral administration, once a day for 12 weeks. Initially, the participant will be treated with Benicar® (olmesartan) 20mg and Natrilix® (indapamide) 1,5 mg. If after 6 weeks the diastolic blood pressure is above 90 mmHg, the dose of Benicar® (olmesartan) will be changed to 40 mg.

Sponsors & Collaborators

  • Brainfarma Industria Química e Farmacêutica S/A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-01
Completion
2023-10-01

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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 NCT05110898 on ClinicalTrials.gov