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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02426099
Other study ID # CNO22011
Secondary ID
Status Completed
Phase Phase 4
First received April 21, 2015
Last updated April 23, 2015
Start date October 2011
Est. completion date October 2012

Study information

Verified date April 2015
Source Yaounde Central Hospital
Contact n/a
Is FDA regulated No
Health authority Cameroon: Ministry of Public Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 75 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Cameroon National Obesity Centre, Yaounde Central Hospital Yaounde Centre

Sponsors (2)

Lead Sponsor Collaborator
Sobngwi Eugene University of Yaounde 1

Country where clinical trial is conducted

Cameroon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy (Blood pressure reduction) Blood pressure reduction 4 weeks No
Secondary Potassium (Change in serum potassium) Change in serum potassium 4 weeks Yes
Secondary Creatinine (Change in serum creatinine) Change in serum creatinine 4 weeks Yes
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