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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00394394
Enrollment
Unknown
Registered
2006-11-01
Start date
2005-02-28
Completion date
Unknown
Last updated
2006-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

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

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.
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.
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.
Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026