Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril

Phase 2

Completed

• Conditions: Hypertension

• Registration Number: NCT00394394
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don't compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent.

This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Status Verified: 2006-10
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Last Update Submitted: 2006-10-30
• Study First Posted: 2006-11-01
• Last Update Posted: 2006-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients who are using Hydrochlorothiazide 25mg/d at least in a four weeks treatment and had their office blood pressure not controlled (systolic or diastolic greater than 140 mmHg or 90 mmHg, respectively).

Exclusion Criteria

• Established cardiovascular disease
• Diabetics in use of insulin
• Impairment renal in renal function
• Contraindications for the study medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who needed to double the dose of enalapril or amiloride in forth or eighth week or use propranolol in the eighth week follow-up visiting.
Fasting blood glucose differences between the baseline and twelve-week follow-up visiting.
Serum potassium differences between the baseline and twelve-week follow-up visiting.
Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting.
Serum uric acid differences between the baseline and twelve-week follow-up visiting.
Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil