Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190333

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 III

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:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Serotonin Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

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 - French Health Products Safety Agency

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
Serotonin
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on February 09, 2012