Ambrisentan (Letairis) for Sarcoidosis Associated Pulmona... | NCT00851929

Studies
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

NCT00851929

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Aug 2, 2018Actual

Enrollment

16Actual

Phase

Phase 2Phase 3

Conditions

Sarcoidosis
Pulmonary Hypertension

Interventions

Ambrisentan

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

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

Nov 2008

Primary Completion Date

Apr 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Feb 24, 2009

First Submission Date that Met QC Criteria

Feb 25, 2009

First Posted Date

Feb 26, 2009Estimated

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

Jul 31, 2018

Last Update Posted Date

Aug 2, 2018Actual

Name	Class
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sarcoidosis associated pulmonary hypertension	Experimental	sarcoidosis associated pulmonary hypertension	Drug: Ambrisentan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ambrisentan	Drug	ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months	sarcoidosis associated pulmonary hypertension

Measure	Description	Time Frame
Change in 6 minute walk distance.		4 months of therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven sarcoidosis
Mean pulmonary artery pressure > 25 mmHg at rest and greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
Pulmonary capillary wedge pressure ≤ 15 mmHg
PVR values >3.0 Woods units
Forced vital capacity (FVC) >40%
WHO functional class II or III
Stable sarcoidosis treatment regimen for three months prior to entry into study
6 minute walk distance between 150-450 meters
Stable dose of antihypertensive medications
On no other medication to treat PAH (sildenafil, tadalafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, sitaxsentan) within one month prior to enrollment and during duration of the study
Non-pregnant females

Exclusion Criteria:

Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
Severe systemic hypertension > 170/95
Patients with congestive heart failure (left ventricular dysfunction) or primary right ventricular dysfunction
Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, etc.)
Use within 1 month of an endothelin receptor antagonists (bosentan, sitaxsentan).
WHO functional class IV status
Patients with significant left ventricular dysfunction
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc A Judson, MD	Medical University of South Carolina	Principal Investigator
Don C Rockey, MD	Medical University of South Carolina	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina Medical Center		Chapel Hill	North Carolina		United States
Medical Univerrsity of South Carolina

Condition Browse Module

MeSH Terms

ID	Term
D012507	Sarcoidosis
D006976	Hypertension, Pulmonary
D004417	Dyspnea

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided