The Role of Endothelin in Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00759408
First received: September 24, 2008
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Pulmonary Hypertension
Drug: BQ-123
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Endothelin in Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • To determine the contribution of endothelin to pulmonary vasoconstriction [ Time Frame: one testing visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the contribution of endothelin to vasoconstriction in primary and secondary hypertension [ Time Frame: one testing visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 1999
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BQ-123
Drug: BQ-123
6-120 µg/min

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • known diagnosis of pulmonary hypertension

Exclusion Criteria:

  • hypertension due to other reasons (not pulmonary)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 24, 2008
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014