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Completed

NCT Number: NCT00394394

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiloride 2,5/d or Enalapril/d 10 mg

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2005
First posted
Nov 1, 2006
Registry last updated
Nov 1, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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