NCT02072382

Brief Summary

The proposed study is to evaluate the possible effect of metformin on arterial pressure by 24h-ambulatory blood pressure monitory (24h-ABPM).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started May 2013

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

September 16, 2013

Last Update Submit

August 25, 2015

Conditions

Hypertension

Keywords

HypertensionMetforminAmbulatory blood pressure monitor

Outcome Measures

Primary Outcomes (1)

  • The effect of metformin on blood pressure

    The primary outcome was the difference in mean 24-hour BP variation between the two groups (metformin versus placebo) after the intervention.

    eight weeks

Secondary Outcomes (1)

  • 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.

    eight weeks

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin 850 mg twice a day for eight weeks versus Placebo

Drug: MetforminDrug: Placebo

Interventions

MetforminDRUG

metformin 850mg twice a day for eight weeks

Also known as: Glucophage
Metformin
PlaceboDRUG
Metformin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertensive patients,
  • aged 18-75 years

You may not qualify if:

  • diabetes
  • metformin intolerance
  • creatinine level above 1.5 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Metformin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Gus Miguel

    Hospital de Clínicas de Porto Alegre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

February 26, 2014

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

BR(1)