Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190333
First received: September 13, 2005
Last updated: February 17, 2011
Last verified: March 2007

September 13, 2005
February 17, 2011
June 2005
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT00190333 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class [ Time Frame: after 16 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale) [ Time Frame: after 16 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of escitalopram in improving the quality of life [ Time Frame: after 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of escitalopram, alone or on top of associated drugs [ Time Frame: after 16 weeks ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: escitalopram
escitalopram
Other Name: escitalopram
Active Comparator: A
Intervention: Drug: escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2008
December 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190333
P020305
Yes
Isabelle BRINDEL, Department of Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Chair: Gerald SIMONNEAU, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

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