Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Pulmonary Arterial Hypertension |
Intervention | Drug: Metformin |
Phase | Phase 2 |
Sponsor | Nantes University Hospital |
Responsible Party | Nantes University Hospital |
ClinicalTrials.gov Identifier | NCT01352026 |
First Received | May 10, 2011 |
Last Updated | August 3, 2012 |
Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 10, 2011 |
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Last Updated Date | August 3, 2012 |
Start Date | May 2011 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | 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. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH) |
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Official Title | Not Provided |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Intervention Model: Single Group Assignment, Masking: Open Label |
Condition | Pulmonary Arterial Hypertension |
Intervention | Drug: Metformin |
Study Arm (s) | Experimental: Metformin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Withdrawn |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01352026 |
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Other Study ID Numbers | BRD10/6-V |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Nantes University Hospital |
Study Sponsor | Nantes University Hospital |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | August 2012 |
Locations[ + expand ][ + ]
CHU de Nantes | Nantes, France, 44093 |
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CHU de Bordeaux | Pessac, France, 33604 |