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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01712997

Acronym

BIPH

Enrollment

Registered

2012-10-24

Start date

2012-09-30

Completion date

Unknown

Last updated

2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Treatment of

Brief 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.

Interventions

DRUGIloprost

DRUGBosentan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change from baseline in 6-min-walk distance (6-MWD)	12 weeks

Secondary

Measure	Time frame
modified (NYHA) functional class	12 weeks

Other

Measure	Time frame
time to clinical worsening	2 years

Countries

China

Contacts

Primary ContactShengqing Li, MD, PhD

shengqingli@gmail.com+86-29-84771132

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026