CClinicalTrials.gg
WithdrawnNCT01352026MetHTAPUpdated Aug 6, 2012

Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)

A Phase 2 interventional study of Metformin in Pulmonary Arterial Hypertension, sponsored by Nantes University Hospital. Withdrawn at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-06.

Sponsored by Nantes University Hospital · Phase 2 and Interventional

Why this study was withdrawn
Several therapeutic have been developed making more difficult the eligibility of patients - Recruitment of new centers wasn't possible due to competing trials
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents.

Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at the pulmonary arteries level.

According to these results, and knowing that metformin is a widely used drug, with a favorable safety profile, the investigators decided to set up a pilot study, in order to evaluate the activity of metformin in PAH treatment. In parallel, the investigators will focus on metformin mechanism of action.

02

Conditions studied

03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Men or women aged between 18 and 80
  • Patients included will have pre-capillary PAH
  • they have to be stable for more than 3 months
  • Patient with a 6-minute walk test comparable over the last 3 months before inclusion
  • Informed consent signed
05

Study design

Phase
Phase 2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Metformin

    Drug: Metformin

Interventions

  • DrugMetformin
06

What researchers measure

Primary outcomes

  1. The primary objective of this study will be to demonstrate the improvement of walk test distance in patients with pulmonary arterial hypertension (PAH) treated by metformin.

07

Study locations

2 sites
  • CHU de Nantes
    Nantes, 44093, France
  • CHU de Bordeaux
    Pessac, 33604, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01352026
Lead sponsor
Nantes University Hospital
First posted
May 11, 2011
Start date
May 2011
Last update
Aug 6, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion