Trial Outcomes & Findings for Placebo Controlled Trial of Bosentan in Scleroderma Patients (NCT NCT00377455)

Results Overview

The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

This will be determined after 16 weeks on the study medication.

Results posted on

2018-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Bosentan and Placebo Arms This group consists of subjects on both arms of the study - bosentan and placebo
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bosentan and Placebo Arms This group consists of subjects on both arms of the study - bosentan and placebo
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Placebo Controlled Trial of Bosentan in Scleroderma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bosentan and Placebo Arms n=5 Participants This group consists of subjects on both arms of the study - bosentan and placebo
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: This will be determined after 16 weeks on the study medication.

The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: Outcomes not available, due to early termination of study

The distance walked during a 6-minute walk test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: Outcomes not available, due to early termination of study

Serum BNP level to evaluate Brain Natriuretic Peptide (BNP) level

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: Outcomes not available, due to early termination of study

From saved serum to determine Endothelian-1 (ET-1) levels in patients

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: Outcomes not available, due to early termination of study

QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).

Outcome measures

Outcome data not reported

Adverse Events

Bosentan and Placebo Arms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Virginia Steen

Georgetown University

Phone: 202-444-6200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place