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

Hypertension Clinical Trial

Official title:

Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394394
• Other study ID #: 04002
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2006
• Last updated: October 30, 2006
• Start date: February 2005

Study information

• Verified date: October 2006
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Amiloride 2,5/d or Enalapril/d 10 mg

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up
Secondary	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.
Secondary	Fasting blood glucose differences between the baseline and twelve-week follow-up visiting.
Secondary	Serum potassium differences between the baseline and twelve-week follow-up visiting.
Secondary	Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting.
Secondary	Serum uric acid differences between the baseline and twelve-week follow-up visiting.
Secondary	Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting.