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

• Sponsor: Hospital de Clinicas de Porto Alegre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00394394
• Collaborator: (none)
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Amiloride 2,5/d or Enalapril/d 10 mg	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.
• Study Start Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up []

Secondary Outcome Measures

1. 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. []

2. Fasting blood glucose differences between the baseline and twelve-week follow-up visiting. []

3. Serum potassium differences between the baseline and twelve-week follow-up visiting. []

4. Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting. []

5. Serum uric acid differences between the baseline and twelve-week follow-up visiting. []

6. Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Brazil	90035-903

Sponsors and Collaborators

• Hospital de Clinicas de Porto Alegre

Investigators

• Principal Investigator: Miguel Gus, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00394394
• Other Study ID Numbers: 04002
• First Posted: Nov 1, 2006
• Last Update Posted: Nov 1, 2006
• Last Verified: Oct 1, 2006

• Additional relevant MeSH terms: Hypertension; Enalapril; Amiloride

Study Results

No Results Posted as of Nov 1, 2006