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

NCT01072669 | Completed Results DMC

• 1 other identifier: nbose2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effectiveness of a drug called ambrisentan, approved by the FDA for use in pulmonary hypertension (a condition where there is increased pressure in the right side of the heart) in scleroderma patients, to see if this medicine may be beneficial in relieving and/or preventing Raynaud's flares in you and other patients like you. This medicine may have some short-term and long-term benefits in persons with scleroderma

Conditions

Ischemia

Keywords

Ambrisentan increases digital micro-vascular flow (measured by LDPI) in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to SSc.

Outcome Measures

Primary Outcomes (1)

• Digital Micro-vascular Flow

  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

  Baseline and 12 weeks

Study Arms (2)

ambrisentan

ACTIVE COMPARATOR

drug arm use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow

Drug: ambrisentan

sugar pill

PLACEBO COMPARATOR

those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients

Drug: ambrisentan

Interventions

ambrisentan DRUG

Subjects will receive ambrisentan 5 mg orally once daily or identical placebo pills for the first 4 weeks and then increased to ambrisentan 10mg once daily\[if the lower dose is tolerated\] or identical placebo pills for the rest of the study. They will be instructed to take the 5mg/pink pills for 4 weeks and then switch to 10mg /red pills unless they are having any drug related side effects or concerns. There will be no routine visit planned at 4 weeks to assess drug tolerance unless a complication arises. Adherence to treatment will be assessed by pill counting at each follow up visit. Follow up digital blood flow measurements will be obtained with LDPI at 1 week and at 3 months, where the same protocol (as that in the initial visit) will be followed.

Also known as: Letairis

ambrisentan; sugar pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Soumya Chatterjee: lead
• Gilead Sciences: collaborator

Study Sites (1)

Nilanjana Bose, Md

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Bose N, Bena J, Chatterjee S. Evaluation of the effect of ambrisentan on digital microvascular flow in patients with systemic sclerosis using laser Doppler perfusion imaging: a 12-week randomized double-blind placebo controlled trial. Arthritis Res Ther. 2015 Mar 5;17(1):44. doi: 10.1186/s13075-015-0558-9.

  PMID: 25876611 DERIVED

MeSH Terms

Conditions

Ischemia

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size and short duration of study Some patients had hand contractures which made the LDPI images somewhat inaccurate Could not adjust for all variables in final analysis Placebo effect reflected in patient responses to questionnaires

Results Point of Contact

• Title: Dr. Soumya Chatterjee
• Organization: Cleveland Clinic

chattes@ccf.org

216-444-9945

Study Officials

• NILANJANA BOSE, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-03

Locations

US (1)