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

Pulmonary Arterial Hypertension Clinical Trial

— BIPH  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01712997
• Other study ID #: BIPH-20121022
• Status: Unknown status
• Phase: Phase 3
• First received: October 22, 2012
• Last updated: February 26, 2014
• Start date: September 2012

Study information

• Verified date: February 2014
• Source: Fourth Military Medical University
• Contact: Shengqing Li, MD, PhD
• Phone: +86-29-84771132
• Email: shengqingli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Iloprost

• Bosentan

Locations

Country	Name	City	State
China	The department of pulmonary and critical care medicine, Tangdu hospital	Xi'an	Shaanxi
China	The department of pulmonary and critical care medicine, Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to clinical worsening		2 years
Primary	change from baseline in 6-min-walk distance (6-MWD)		12 weeks
Secondary	modified (NYHA) functional class		12 weeks