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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01072669
• Date of registration: 19/02/2010
• Prospective Registration: No
• Primary sponsor: Soumya Chatterjee
• Public title: Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet ambrisentan
• Scientific title: Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging
• Date of first enrolment: February 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01072669
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: NILANJANA BOSE, MD
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects should have limited scleroderma with disease duration <7 years and should
satisfy American College of Rheumatology criteria for diagnosis.9;

- 10 Raynaud's phenomenon would be defined as episodic, bilateral, digital color changes
(at least 2 out of 3 possible phases:

- pallor, cyanosis, rubor),

- provoked by cold or emotional stress.

- Subjects should be between 18 and 70 years of age and be able to give informed
consent.

Exclusion Criteria:

- (a) current tobacco users,

- (b) advanced cardiopulmonary disease,

- (c) clinically unstable patient,

- (d) presence of active digital ulcers or prior history of digital ulcers which led to
scarring or significant pitting of digits in the area of interest(presence of ulcers
or pits would interfere with measurement of blood flow by LDPI),

- (e) pregnancy (class X in pregnancy) or unable to use two reliable forms of
contraception during the study if patient is of child bearing age,

- (f) patients with moderate or severe hepatic impairment

- (g) hemoglobin values less than 10% of the lower limit of normal per laboratory
standards

- (h) inability to discontinue vasodilator treatment including calcium channel blockers,
nitrates, alpha blockers, PDE-5 inhibitors, ACE inhibitors and angiotensin receptor
blockers at least one week prior to the study,

- (i) echocardiographic evidence of pulmonary arterial hypertension [estimated right
ventricular systolic pressure <35 mm Hg],

- (j) based on section 7.3 of the full prescribing information booklet- patients on
cyclosporine, rifampin or ritonavir should be excluded,

- (k) patients with diffuse disease,

- (l) disease duration > 7 years



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ischemia

Intervention(s)

Drug: ambrisentan

Primary Outcome(s)

Digital Micro-vascular Flow [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

nbose2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences

Results

• Results available: Yes
• Date Posted: 03/05/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01072669