Double Blind, Randomized Trial of Bosentan for Sarcoidosi... | NCT00581607

Studies
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

NCT00581607

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Apr 12, 2013Estimated

Enrollment

43Actual

Phase

Phase 2Phase 3

Conditions

Sarcoidosis
Pulmonary Arterial Hypertension

Interventions

Bosentan
Placebo
Bosentan
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
7-3-22-1

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Oct 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2013

Last Update Posted Date

Apr 12, 2013Estimated

Name	Class
Actelion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.

Detailed Description

Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bosentan for 16 weeks	Active Comparator	Active drug	Drug: Bosentan
Placebo	Placebo Comparator	Placebo for 16 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bosentan	Drug	62.5 mg bid for 4 weeks, then 125 mg bid	Bosentan for 16 weeks

Measure	Description	Time Frame
Improvement in six minute walk distance		16 weeks

Measure	Description	Time Frame
Change in pulmonary hemodynamics		16 weeks
Improvement in quality of life with therapy		48 weeks
Safety of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with known sarcoidosis 21.
Age 18 or greater
Patients with documented pulmonary hypertension with a PA mean > 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg.
Patients with WHO class II or III
Six minute walk distance of between 100 to 500 meters
Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
Patients able to provide written consent

Exclusion Criteria:

Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
Patients with World Health Organization (WHO) class IV status.
Patients who are pregnant or breast feeding
Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
Cardiac index < 2.0 liters and/or right atrial pressure >15 mm Hg
Significant liver dysfunction not due to sarcoidosis.
Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
Patients unable to perform the 6 minute walk study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert P Baughman, MD	University of Cincinnati	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai		New York	New York		United States
University of Cincinnati

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24177203	Derived	Baughman RP, Culver DA, Cordova FC, Padilla M, Gibson KF, Lower EE, Engel PJ. Bosentan for sarcoidosis-associated pulmonary hypertension: a double-blind placebo controlled randomized trial. Chest. 2014 Apr;145(4):810-817. doi: 10.1378/chest.13-1766.

Type	Date	Date Unknown
Release	Jan 30, 2018
Reset	Feb 27, 2018

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

ID	Term
D012507	Sarcoidosis
D000081029	Pulmonary Arterial Hypertension