Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190333
• Other study ID #: P020305
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: February 17, 2011
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• escitalopram
escitalopram

Locations

Country	Name	City	State
France	Louis Pradel Hospital	Bron
France	Antoine Beclere Hospital	Clamart
France	Henri Mondor Hospital	Creteil
France	Michallon Hospital	Grenoble
France	Sainte Marguerite Hospital	Marseille
France	Haut Lévèque Hospital	Pessac
France	Hautepierre Hospital	Strasbourg
France	Rangueil Hospital	Toulouse
France	Brabois Hospital	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		for 16 weeks	Yes
Secondary	To evaluate the efficacy of escitalopram in improving hemodynamic parameters (right heart catheterization; decision of doing right heart catheterization belonging to the investigators)		after 16 weeks	Yes
Secondary	To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class		after 16 weeks	Yes
Secondary	To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale)		after 16 weeks	Yes
Secondary	To evaluate the efficacy of escitalopram in improving the quality of life		after 16 weeks	Yes
Secondary	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		after 16 weeks	Yes
Secondary	To evaluate the safety of escitalopram, alone or on top of associated drugs		after 16 weeks	Yes