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The Role of Endothelin in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT00759408
Recruitment Status : Unknown
Verified April 2010 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : May 5, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: BQ-123 Phase 2

Detailed Description:
Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Endothelin in Pulmonary Hypertension
Study Start Date : February 1999
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
BQ-123
Drug: BQ-123
6-120 µg/min


Outcome Measures

Primary Outcome Measures :
  1. To determine the contribution of endothelin to pulmonary vasoconstriction [ Time Frame: one testing visit ]

Secondary Outcome Measures :
  1. To determine the contribution of endothelin to vasoconstriction in primary and secondary hypertension [ Time Frame: one testing visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • known diagnosis of pulmonary hypertension

Exclusion Criteria:

  • hypertension due to other reasons (not pulmonary)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759408


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Mark A Creager, MD Brigham and Women's Hospital
More Information

Responsible Party: Mark A. Creager, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00759408     History of Changes
Other Study ID Numbers: 1999-P-003126
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: April 2010

Keywords provided by Brigham and Women's Hospital:
primary pulmonary hypertension
secondary pulmonary hypertension due to left heart failure
secondary pulmonary hypertension due to other causes
patients without pulmonary disease or pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
cyclo(Trp-Asp-Pro-Val-Leu)
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action