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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01712997
Other study ID # BIPH-20121022
Secondary ID
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
Health authority
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. completion date
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

Study Design


Related Conditions & MeSH terms


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
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