- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00394394
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up
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Secondary Outcome Measures
Outcome Measure |
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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.
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Fasting blood glucose differences between the baseline and twelve-week follow-up visiting.
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Serum potassium differences between the baseline and twelve-week follow-up visiting.
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Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting.
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Serum uric acid differences between the baseline and twelve-week follow-up visiting.
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Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting.
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Collaborators and Investigators
Investigators
- Principal Investigator: Miguel Gus, Hospital de Clinicas de Porto Alegre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Diuretics, Potassium Sparing
- Acid Sensing Ion Channel Blockers
- Epithelial Sodium Channel Blockers
- Enalapril
- Amiloride
Other Study ID Numbers
- 04002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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