- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712997
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients (BIPH)
February 26, 2014 updated by: Shengqing Li, Air Force Military Medical University, China
Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shengqing Li, MD, PhD
- Phone Number: +86-29-84771132
- Email: shengqingli@gmail.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- The department of pulmonary and critical care medicine, Tangdu hospital
-
Contact:
- Yonghong Xie, MD
- Phone Number: +86-29-84777725
- Email: xieyh65@yahoo.com.cn
-
Principal Investigator:
- Yonghong Xie, MD
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- The department of pulmonary and critical care medicine, Xijing hospital
-
Contact:
- Xinpeng Han, MD
- Phone Number: +86-29-84775237
- Email: hxp0728@163.com
-
Sub-Investigator:
- Xinpeng Han, MD
-
Sub-Investigator:
- Yongping Yu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combination therapy
combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
|
|
Active Comparator: monotherapy
Bosentan,125mg,po,bid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in 6-min-walk distance (6-MWD)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
modified (NYHA) functional class
Time Frame: 12 weeks
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to clinical worsening
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shengqing Li, MD, PhD, The department of pulmonary and critical care medicine, Xijing hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
October 22, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (Estimate)
October 24, 2012
Study Record Updates
Last Update Posted (Estimate)
February 27, 2014
Last Update Submitted That Met QC Criteria
February 26, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hypertension, Pulmonary
- Hypertension
- Pulmonary Arterial Hypertension
- Familial Primary Pulmonary Hypertension
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Platelet Aggregation Inhibitors
- Endothelin Receptor Antagonists
- Iloprost
- Bosentan
Other Study ID Numbers
- BIPH-20121022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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