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

This study is currently recruiting participants.
Verified October 2012 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Shengqing Li, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01712997
First received: October 22, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Bosentan,125mg,po,bid.
 Drug: Bosentan

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 dyn.s.cm-5 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712997

Contacts
Contact: Shengqing Li, MD, PhD +86-29-84771132 shengqingli@gmail.com

Locations
China, Shaanxi
The department of pulmonary and critical care medicine, Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Xinpeng Han, MD     +86-29-84775237     hxp0728@163.com    
Sub-Investigator: Xinpeng Han, MD            
Sub-Investigator: Yongping Yu, MD            
The department of pulmonary and critical care medicine, Tangdu hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yonghong Xie, MD     +86-29-84777725     xieyh65@yahoo.com.cn    
Principal Investigator: Yonghong Xie, MD            
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Shengqing Li, MD, PhD The department of pulmonary and critical care medicine, Xijing hospital
  More Information

No publications provided

Responsible Party: Shengqing Li, Associate Chief Physician, Associate Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01712997     History of Changes
Other Study ID Numbers: XJ-BIT20121022
Study First Received: October 22, 2012
Last Updated: October 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
Treatment of

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Bosentan
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013