Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril - Full Text View

Sponsor:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00394394

Purpose

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	Intervention	Phase
Hypertension	Drug: Amiloride 2,5/d or Enalapril/d 10 mg	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Hydrochlorothiazide Enalapril Enalapril maleate Enalaprilat Amiloride

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

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

Secondary Outcome 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.

Study Start Date:

February 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394394

Locations

Brazil
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

More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Guerrero P, Fuchs FD, Moreira LM, Martins VM, Bertoluci C, Fuchs SC, Gus M. Blood pressure-lowering efficacy of amiloride versus enalapril as add-on drugs in patients with uncontrolled blood pressure receiving hydrochlorothiazide. Clin Exp Hypertens. 2008 Oct;30(7):553-64.

ClinicalTrials.gov Identifier:	NCT00394394 History of Changes
Other Study ID Numbers:	04002
Study First Received:	October 30, 2006
Last Updated:	October 30, 2006
Health Authority:	Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Hydrochlorothiazide
Enalapril
Enalaprilat
Antihypertensive Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012