Official Title: “Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

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

Primary Measures

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

Secondary Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Overall Clinical Trial Officials and Contacts

Miguel Gus Principal Investigator Hospital de Clínicas de Porto Alegre  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00394394

Study ID Number: 04002

ClinicalTrials.gov Identifier: NCT00394394

Health Authority: Brazil: National Committee of Ethics in Research