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Trial record 54 of 235 for:    PRASTERONE

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

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ClinicalTrials.gov Identifier: NCT01273259
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Bordeaux.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE January 7, 2011
First Posted Date  ICMJE January 10, 2011
Last Update Posted Date January 10, 2011
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
Efficacy of DHEA on exercise capacity (six-minute walk test) [ Time Frame: inclusion and one year of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
  • Pulmonary and systemic arterial pressures (mean, systolic and diastolic) [ Time Frame: Inclusion and after one year of treatment ]
  • Pulmonary vascular resistances [ Time Frame: Inclusion and after one year of treatment ]
  • Safety / Compliance [ Time Frame: along one year of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Official Title  ICMJE Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
Brief Summary DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Hypertension, Pulmonary
Intervention  ICMJE
  • Drug: DHEA Treatment
    DHEA : 200 mg/day hard gelatine capsule
  • Drug: DHEA Treatment
    DHEA : 25 mg/day hard gelatine capsule
Study Arms  ICMJE
  • Experimental: 200 mg /day arm
    Intervention: Drug: DHEA Treatment
  • Experimental: 25 mg/day arm
    Intervention: Drug: DHEA Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 7, 2011)
8
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years old and ≤ 75 years old
  • Chronic Obstructive Pulmonary Disease with FEVs/VC < 70% (*)
  • Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmHg (*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
  • PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
  • If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
  • Written informed consent

(*) Criteria assessed from last health check or the last exams for COPD diagnosis

Exclusion Criteria:

  • clinical instability and/or respiratory exacerbation dangerous for catheterization
  • Pregnancy (ßHCG > 20 UI /l) or breastfeeding on going
  • General corticotherapy > 0,5 mg/kg/day prednisolon equivalent
  • Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
  • Left-heart failure (coronary heart disease and/or left valvulopathy)
  • High level of prostatic specific antigen (PSA) (> 7ng/ml)
  • Cancer antecedent or treatment on going
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01273259
Other Study ID Numbers  ICMJE CHUBX 2003/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bordeaux
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP