The Hypotensive Effect of Metformin in Hypertensive Patients. | RxWiki

The Hypotensive Effect of Metformin in Hypertensive Patients.

Overview[ - collapse ][ - ]

Purpose	The proposed study is to evaluate the possible effect of metformin on arterial pressure by 24h-ambulatory blood pressure monitory (24h-ABPM).
Condition	Hypertension
Intervention	Drug: Metformin Drug: Placebo
Phase	Phase 4
Sponsor	Hospital de Clinicas de Porto Alegre
Responsible Party	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier	NCT02072382
First Received	September 16, 2013
Last Updated	February 25, 2014
Last verified	May 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 16, 2013
Last Updated Date	February 25, 2014
Start Date	May 2013
Estimated Primary Completion Date	May 2015
Current Primary Outcome Measures	The effect of metformin on blood pressure [Time Frame: eight weeks] [Designated as safety issue: No]The primary outcome was the difference in mean 24-hour BP variation between the two groups (metformin versus placebo) after the intervention.
Current Secondary Outcome Measures	The difference in mean of BP during daytime and nighttime in ABPM-24h, as well as the office BP and laboratory differences were considered secondary outcomes. [Time Frame: eight weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	The Hypotensive Effect of Metformin in Hypertensive Patients.
Official Title	The Hypotensive Effect of Simvastatin in Hypertensive Patients: a Placebo-controlled Randomized Clinical Trial With 24-h Ambulatory Blood Pressure Monitoring
Brief Summary	The proposed study is to evaluate the possible effect of metformin on arterial pressure by 24h-ambulatory blood pressure monitory (24h-ABPM).
Detailed Description	The primary outcome was the difference in mean 24-hour blood pressure variation between the two groups after the intervention. The difference in mean of blood pressure during daytime and nighttime in 24h ambulatory blood pressure monitory, as well as the office BP and laboratory differences were considered secondary outcomes. This randomized, double-blind parallel study was conducted in the Hypertension Clinic of the Department of Cardiology, Hospital de Clínicas de Porto Alegre (Porto Alegre, Brazil). We selected hypertensive individuals (controlled or not) without diabetes aged 18-70 years. Exclusion criteria: metformin intolerance, creatinine > 1,5 mg/dl Risks: adverse effects related to metformin use, mainly diarrhea and nausea Benefits: possible lower effect on arterial pressure Statistical analysis: sample size was calculated on the basis of a standard deviation of 8 mm Hg and effect size of 5 mm Hg in 24-h systolic ABPM and a two-sided significance level of 5%. A sample size of 42 patients per group was estimated to provide a power of 80% to reject the null hypothesis. Considering possible 10% of losses, the final calculated sample was 92 patients. The baseline comparison between groups was performed using the Student t test for continuous variables and x2 for categorical variables. In each group, the change in BP by ABPM -24 h, daytime and nighttime, and laboratory tests was calculated by subtracting baseline values measured after the intervention period. The difference between groups was calculated by subtracting the variation observed between them (δ-values). The differences in BP variation and laboratory tests were analyzed by analysis of variance for repeated measures (MANOVA). For differences in pressure variation adjustment was considered for the baseline BP values (analysis of covariance). All tests were two-tailed and significance level was 5%. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 13.0.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Hypertension
Intervention	Drug: Metformin metformin 850mg twice a day for eight weeks Other Names: GlucophageDrug: Placebo
Study Arm (s)	Experimental: Metformin Metformin 850 mg twice a day for eight weeks versus Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	92
Estimated Completion Date	May 2015
Estimated Primary Completion Date	December 2014
Eligibility Criteria	Inclusion Criteria: - hypertensive patients, - aged 18-75 years Exclusion Criteria: - diabetes - metformin intolerance - creatinine level above 1.5 mg/dL
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT02072382
Other Study ID Numbers	120406
Has Data Monitoring Committee	Yes
Information Provided By	Hospital de Clinicas de Porto Alegre
Study Sponsor	Hospital de Clinicas de Porto Alegre
Collaborators	Not Provided
Investigators	Study Chair: Gus Miguel Hospital de Clínicas de Porto Alegre
Verification Date	May 2013

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