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Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension

Information source: Yaounde Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus

Intervention: Low dose spironolactone (Drug); Routine intensification of antihypertensive treatment (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Sobngwi Eugene

Official(s) and/or principal investigator(s):
Jean-Claude Mbanya, MD, PhD, Study Chair, Affiliation: University of Yaounde 1


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.

Clinical Details

Official title: Prevalence and Treatment of Resistant Hypertension in Diabetic Patients in Yaounde

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy (Blood pressure reduction)

Secondary outcome:

Potassium (Change in serum potassium)

Creatinine (Change in serum creatinine)


Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Resistant hypertension

- Diabetes mellitus

Exclusion Criteria:

- T2DM with overt acute/chronic complications,

- serum potassium ≥ 5. 5 mmol/l,

- estimated Glomerular Filtration Rate (eGFR) calculated using the Modification of Diet

in Renal Disease formula ≤ 30 ml/min/1. 73m² of body weight,

- absolute contraindication to any of the drug regimen of the trial,

- and current aldosterone antagonist treatment or cessation within the last 15 months

Locations and Contacts

National Obesity Centre, Yaounde Central Hospital, Yaounde, Centre, Cameroon
Additional Information

Starting date: October 2011
Last updated: April 23, 2015

Page last updated: August 23, 2015

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