Trial Outcomes & Findings for Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet (NCT NCT01072669)

Results Overview

Change in digital micro-vascular flow measured by LDPI in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2013-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ambrisentan drug arm use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow	Sugar Pill those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
Overall Study STARTED	15	5
Overall Study COMPLETED	15	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ambrisentan n=15 Participants drug arm use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow	Sugar Pill n=5 Participants those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients	Total n=20 Participants Total of all reporting groups
Age Continuous	50.6 years STANDARD_DEVIATION 12.8 • n=5 Participants	46.8 years STANDARD_DEVIATION 10.5 • n=7 Participants	49.7 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	5 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Assuming a standard deviation of 0.40, and use of a two-sample t-test with significance level of 0.05, there will be 80% power to detect differences in the change from baseline of at least 0.65 units if moderate correlation (r=0.50) exists, and 0.45 units if strong correlation (r=0.75) exists between treated

Change in digital micro-vascular flow measured by LDPI in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks

Outcome measures

Outcome measures
Measure	Ambrisentan n=15 Participants Ambrisentan 5 mg daily for 1 month, then 10 mg daily for 2 months	Sugar Pill n=5 Participants Placebo, same appearing as Ambrisentan
Digital Micro-vascular Flow 12 weeks	-.01 perfusion unit Interval -0.28 to 0.25	-.06 perfusion unit Interval -0.51 to 0.39
Digital Micro-vascular Flow 1 week	.11 perfusion unit Interval -0.15 to 0.37	.18 perfusion unit Interval -0.27 to 0.63

Adverse Events

Ambrisentan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

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. Soumya Chatterjee

Cleveland Clinic

Phone: 216-444-9945

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place