Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
NCT ID: NCT01712997
Last Updated: 2014-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
90 participants
INTERVENTIONAL
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination therapy
combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
Iloprost
Bosentan
monotherapy
Bosentan,125mg,po,bid.
Bosentan
Interventions
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Iloprost
Bosentan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
80 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Shengqing Li
Associate Chief Physician, Associate Professor
Principal Investigators
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Shengqing Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The department of pulmonary and critical care medicine, Xijing hospital
Locations
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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, China
Countries
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Central Contacts
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Facility Contacts
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References
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Han X, Zhang Y, Dong L, Fang L, Chai Y, Niu M, Yu Y, Liu L, Yang X, Qu S, Li S. Treatment of Pulmonary Arterial Hypertension Using Initial Combination Therapy of Bosentan and Iloprost. Respir Care. 2017 Apr;62(4):489-496. doi: 10.4187/respcare.05280. Epub 2017 Jan 24.
Other Identifiers
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BIPH-20121022
Identifier Type: -
Identifier Source: org_study_id
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