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Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients (BIPH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Fourth Military Medical University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Shengqing Li, Fourth Military Medical University Identifier:
First received: October 22, 2012
Last updated: February 26, 2014
Last verified: February 2014
Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Iloprost
Drug: Bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients

Resource links provided by NLM:

Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • change from baseline in 6-min-walk distance (6-MWD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • modified (NYHA) functional class [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • time to clinical worsening [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination therapy
combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
Drug: Iloprost Drug: Bosentan
Active Comparator: monotherapy
Drug: Bosentan


Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 10 to 80
  • treatment naive symptomatic PAH
  • 6-MWD of 100-425 m
  • resting mean pulmonary artery pressure greater than 25 mm Hg, pulmonary capillary wedge pressure less than 15 mm Hg, and pulmonary vascular resistance of 240 or greater.

Exclusion Criteria:

  • Patients with thromboembolic disease,
  • untreated obstructive sleep apnea,
  • portal hypertension,
  • chronic liver disease or renal insufficiency,
  • left-sided or unrepaired congenital heart disease,
  • substantial obstructive (FEV1/FVC<50% predicted) or restrictive (total lung capacity<60% predicted) lung disease
  • Patients receiving phosphodiesterase inhibitors or other prostanoids and endothelin receptor antagonists
  Contacts and Locations
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Please refer to this study by its identifier: NCT01712997

China, Shaanxi
The department of pulmonary and critical care medicine, Tangdu hospital
Xi'an, Shaanxi, China, 710032
The department of pulmonary and critical care medicine, Xijing hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Principal Investigator: Shengqing Li, MD, PhD The department of pulmonary and critical care medicine, Xijing hospital
  More Information

Responsible Party: Shengqing Li, Associate Chief Physician, Associate Professor, Fourth Military Medical University Identifier: NCT01712997     History of Changes
Other Study ID Numbers: BIPH-20121022 
Study First Received: October 22, 2012
Last Updated: February 26, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
Treatment of

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on January 17, 2017