NCT05110898

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

Randomized, Single-Blind, Multicenter, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Brainfarma Industria Química e Farmacêutica S/A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed for the treatment of essential hypertension. It is performed in participants of both sexes, over 18 years of age, who have essential hypertension with diastolic blood pressure between 90 mmHg and 110 mmHg. The rationale for studying the fixed dose combination is the possibility to enhance compliance and simplify treatment.

Conditions

• Hypertension
• Hypertension,Essential

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-10-01
• First posted: 2021-11-08
• Last updated: 2022-03-21