The Role of Endothelin in Pulmonary Hypertension

NCT00759408 | Completed Phase 2 Results DMC

• 1 other identifier: 1999-P-003126
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary Vascular Resistance (PVR)

  PVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.

  Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Secondary Outcomes (3)

• Systemic Vascular Resistance (SVR)

  Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

• Mean Pulmonary Artery Pressure (PAP)

  Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

• Cardiac Output (CO)

  Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Study Arms (1)

1

EXPERIMENTAL

BQ-123

Drug: BQ-123

Interventions

BQ-123 DRUG

6-120 µg/min

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers or known diagnosis of pulmonary hypertension

You may not qualify if:

• hypertension due to other reasons (not pulmonary)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Familial Primary Pulmonary Hypertension

Interventions

cyclo(Trp-Asp-Pro-Val-Leu)

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anju Nohria, MD
• Organization: Brigham and Women's Hospital

ANOHRIA@PARTNERS.ORG

617-525-6852

Study Officials

• Mark A Creager, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: February 1, 1999
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 27, 2018
• Results First Posted: October 24, 2018

Record last verified: 2018-11

Locations

US (1)