Status:
COMPLETED
Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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/pl...
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00190333
Start Date
June 1 2005
End Date
December 1 2008
Last Update
February 18 2011
Active Locations (9)
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1
Louis Pradel Hospital
Bron, France, 69677
2
Antoine Beclere Hospital
Clamart, France, 92140
3
Henri Mondor Hospital
Créteil, France, 94010
4
Michallon Hospital
Grenoble, France, 38043