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

Information source: Hospital de Clinicas de Porto Alegre
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Amiloride 2,5/d or Enalapril/d 10 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Miguel Gus, Principal Investigator, Affiliation: Hospital de Clínicas de Porto Alegre

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.

Clinical Details

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

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

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

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903, Brazil
Additional Information

Starting date: February 2005
Last updated: October 30, 2006

Page last updated: June 20, 2008

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