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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00394394
First received: October 30, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Antihypertensive Agents
Enalapril
Enalaprilat
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing
Cardiovascular Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014