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
  Purpose

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).


Condition Intervention Phase
Pulmonary Hypertension
Drug: escitalopram
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: escitalopram
escitalopram
Other Name: escitalopram

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190333

Locations
France
Louis Pradel Hospital
Bron, France, 69677
Antoine Beclere Hospital
Clamart, France, 92140
Henri Mondor Hospital
Creteil, France, 94010
Michallon Hospital
Grenoble, France, 38043
Sainte Marguerite Hospital
Marseille, France, 13009
Haut Lévèque Hospital
Pessac, France, 33604
Hautepierre Hospital
Strasbourg, France, 67200
Rangueil Hospital
Toulouse, France, 31059
Brabois Hospital
Vandoeuvre les Nancy, France, 54500
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Gerald SIMONNEAU, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190333     History of Changes
Other Study ID Numbers: P020305
Study First Received: September 13, 2005
Last Updated: February 17, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
pulmonary hypertension
6 minutes walking test
serotonin
primary or associated pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 11, 2014