Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension

NCT00190333 | Completed Phase 3 DMC

• 1 other identifier: P020305
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 9

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/placebo 1).

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; 6 minutes walking test; serotonin; primary or associated pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class

  after 16 weeks

• To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale)

  after 16 weeks

• To evaluate the efficacy of escitalopram in improving the quality of life

  after 16 weeks

• 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

Study Arms (1)

A

ACTIVE COMPARATOR

Drug: escitalopram

Interventions

escitalopram DRUG

escitalopram

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (9)

Louis Pradel Hospital

Bron, 69677, France

Location

Antoine Beclere Hospital

Clamart, 92140, France

Location

Henri Mondor Hospital

Créteil, 94010, France

Location

Michallon Hospital

Grenoble, 38043, France

Location

Sainte Marguerite Hospital

Marseille, 13009, France

Location

Haut Lévèque Hospital

Pessac, 33604, France

Location

Hautepierre Hospital

Strasbourg, 67200, France

Location

Rangueil Hospital

Toulouse, 31059, France

Location

Brabois Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gerald SIMONNEAU, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 18, 2011

Record last verified: 2007-03

Locations

FR (9)