Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00190333
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date February 18, 2011
Study Start Date  ICMJE June 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
To evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day on the 6-minute walking test in patients with pulmonary hypertension [ Time Frame: for 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day for 16 weeks on the 6-minute walking test in patients with pulmonary hypertension.
Change History Complete list of historical versions of study NCT00190333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
  • To evaluate the efficacy of escitalopram in improving hemodynamic parameters (right heart catheterization; decision of doing right heart catheterization belonging to the investigators) [ Time Frame: after 16 weeks ]
  • To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class [ Time Frame: after 16 weeks ]
  • To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale) [ Time Frame: after 16 weeks ]
  • To evaluate the efficacy of escitalopram in improving the quality of life [ Time Frame: after 16 weeks ]
  • To evaluate the efficacy of escitalopram in reducing exacerbations of signs or symptoms of the disease that would otherwise require hospital admission or treatment intensification, particularly treatment with bosentan or IV administration of epoprostenol [ Time Frame: after 16 weeks ]
  • To evaluate the safety of escitalopram, alone or on top of associated drugs [ Time Frame: after 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • To evaluate after 16 weeks:
  • • the efficacy of Escitalopram in improving hemodynamic parameters (right heart catheterization);
  • (decision of doing right heart catheterization belonging to the investigators)
  • • the efficacy of Escitalopram in improving the NYHA class;
  • • the efficacy of Escitalopram in improving the dyspnea (visual analog scale);
  • • the efficacy of Escitalopram in improving the quality of life
  • • the efficacy of Escitalopram in reducing exacerbations of signs or symptoms of the disease that would otherwise require hospital admission or treatment intensification, particularly treatment with Bosentan or intravenous administration of epoprostenol
  • and the safety of Escitalopram, alone or on top of associated drugs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
Official Title  ICMJE Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated
Brief Summary This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization ratio, escitalopram 2/placebo 1).
Detailed Description Primary objective: to evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day for 16 weeks on the 6-minute walking test in patients with pulmonary hypertension.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE Drug: escitalopram
escitalopram
Study Arms  ICMJE Active Comparator: A
Intervention: Drug: escitalopram
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects who meet all the criteria listed below will be considered for study inclusion:

  • Male or female older than 18 years of age
  • Meeting World Health Organization (WHO) criteria for pulmonary hypertension (mean pulmonary arterial pressure [PAP] > 25 mmHg at rest and pulmonary capillary wedge pressure < 15 mmHg during right heart catheterization):

    • primary pulmonary hypertension (sporadic or familial), or
    • pulmonary hypertension associated with connective tissue diseases, or
    • pulmonary hypertension associated with HIV infection, or
    • pulmonary hypertension associated with use of appetite suppressants or other toxic compounds, or
    • pulmonary hypertension associated with shunting through a congenital heart defect surgically treated
  • Class II or III in the NYHA classification scheme
  • With a 6-minute walking test distance between 40% and 80% of theoretical values (approximately 50 and 480 m)
  • On conventional treatment, with no change in this treatment during the last month preceding the study. Conventional treatment includes calcium antagonists or beraprost.
  • Subject who consents to participate in the study.

Exclusion Criteria:

Subjects with any of the following clinical features will not be included in the study:

  • Pulmonary hypertension related to aortic or mitral valve disease, or extrinsic pulmonary vein compression
  • Pulmonary hypertension related to hypoxia from respiratory disease with a total lung capacity < 70% or Tiffeneau index < 60% upon testing within the last 6 months (chronic obstructive lung disease, interstitial disease, sleep apnea syndrome, alveolar hypoventilation, chronic exposure to high altitudes, neonatal lung disease, or alveolar capillary dysplasia)
  • Pulmonary hypertension associated with portal hypertension
  • Pulmonary hypertension secondary to chronic thrombosis and/or embolism (occlusion of the proximal or distal pulmonary arteries by thrombosis)
  • In the 6-minute walking test, inability to walk for 6 minutes, for any reason, or walking distance of less than 50 m
  • Pregnancy, lactation, women of childbearing potential (if needed, effective contraception will be prescribed)
  • History of hypersensitivity to citalopram or to medications structurally related to citalopram
  • Treatment with another investigational drug within the 3 months preceding study inclusion
  • Cardiovascular, hepatic, neurological or endocrine disease that is clinically significant, or any other significant disease that may interfere with the study protocol or with the interpretation of study findings
  • History of drug or alcohol abuse
  • Liver failure (except abnormalities related to the right ventricular failure)
  • Kidney failure
  • Mental status preventing the patient from understanding the nature, objectives, and possible consequences of the study
  • Non stabilized psychiatric disorders
  • Subject unable to comply with protocol-related constraints (e.g., uncooperative, unable to attend follow-up visits, and probably unable to complete the study).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT00190333
Other Study ID Numbers  ICMJE P020305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabelle BRINDEL, Department of Clinical Research of developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gerald SIMONNEAU, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2007

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