Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension
NCT02426099 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2015-04-24
Summary
This is a four-week randomized controlled single blinded trial of subjects presenting with resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to routine intensification of antihypertensive regimen , all added to previous regimen with unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four following add-on therapy initiation. The primary outcome is change in office and self-measurement blood pressure recorded at each visit, and secondary outcomes are variations in serum potassium, sodium, and creatinine levels.
Conditions
- Hypertension, Resistant to Conventional Therapy
- Diabetes Mellitus
Interventions
- DRUG
-
Low dose spironolactone
4-week add-on low dose spironolactone in resistant hypertension
- OTHER
-
Routine intensification of antihypertensive treatment
4-week guidelines oriented intensification of antihypertensive treatment
Sponsors & Collaborators
-
University of Yaounde 1
collaborator OTHER -
Sobngwi Eugene
lead OTHER_GOV
Principal Investigators
-
Jean-Claude Mbanya, MD, PhD · University of Yaounde 1
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2012-10-31
- Completion
- 2012-10-31
Countries
- Cameroon
Study Locations
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