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1 Clinical Trial Details (PDF Generation Date :- Fri, 09 Nov :53:13 GMT) CTRI Number Last Modified On 30/07/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 22/05/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis(scleroderma) Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) AC-055C301 / DUAL-1 version 3 dated 26 August NCT Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Sarath Chandra Mouli Veervalli Chief Rheumatologist Phone Fax Krishna Institute of Medical Sciences Ltd Krishna Institute of Medical Sciences Ltd, /1, Minister Road, Secunderabad Krishna Institute of Medical Sciences Ltd, /1, Minister Road, Secunderabad sarath10@hotmail.com Details Contact Person (Public Query) Christo Mannil Senior Clinical Research Associate ClinTec () International Pvt. Ltd ClinTec () International Pvt. Ltd #380, 2nd Floor, Ittina Center, Koramangala 3rd Block, Bangalore. ClinTec () International Pvt. Ltd #380, 2nd Floor, Ittina Center, Koramangala 3rd Block, Bangalore. page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Bangalore KARNATAKA Phone Fax > ACTELION Pharmaceuticals Ltd. Source of Monetary or Material Support Primary Sponsor Details ACTELION Pharmaceuticals Ltd ACTELION Pharmaceuticals Ltd. Gewerbestrasse 16 CH 4123 Allschwil Switzerland. Type of Sponsor ClinTec International Pvt Ltd List of Countries Australia Belarus Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Finland France Germany Hungary Italy Poland Russian Federation Ukraine United States of America of Principal Investigator Dr Sarvejeet Pal Pharmaceutical industry-global ClinTec () International Pvt. Ltd. 380, 2nd Floor, ITTINA Centre Service Road, Koramangala 3rd Block Near Kormangala Water Tank Bangalore of Site Site Phone/Fax/ Advance Rheumatology Clinic Department of Rheumatology and Immunology. 1st Floor, Kautilya. Besides Medinova Complex. Somajiguda Dr Debashish Danda Christian Medical Department of Clinical page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr Sarath Chandra Mouli Veeravalli College Krishna Institute of Medical Sciences Ltd. Immunology and Rheumatology. Ida Scudder Road. Vellore Vellore TAMIL NADU Department of Rheumatology /1, Minister Road, Secunderabad. debashish.danda@cmc vellore.ac.in sarath10@hotmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Ethics Committee,. PI is Dr. Sarvajeet Pal Approved 19/03/2012 Yes Institutional Ethics Committee, Secunderabad. PI is Dr. Sarath Chandra Mouli. Affiliated to Krishna Institute of Medical Sciences Approved 16/04/2012 No Institutional Review Board, Vellore. PI is Dr. Debashish Danda. Affiliated to Christian Medical College. Status Approved 06/07/2012 No Date No Objection Certificate 03/04/2012 Health Type Patients Condition Digital Ulcers Associated with Systemic Sclerosis. Type Details Intervention Macitentan Macitentan 10mg q.d up to 25 months, oral. Intervention Macitentan Macitentan 3mg q.d upto 25 months, oral. Comparator Agent Placebo Placebo q.d upto 25 months, oral. Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR), or having ever met criteria for CREST syndrome (with sclerodactyly and 2 out of the 4 remaining criteria: calcinosis,raynauds phenomenon, esophageal dysfunction, telangiectasia). 2.At least one visible, active ischemic DU at baseline, located at or distal to the proximal interphalangeal joints (PIP) or at the digital tip, and that developed or worsened within 8 weeks prior to sreening. page 3 / 5

4 3.History of at least one additional active ischemic DU within 6 months, or at least two within 12 months prior to Screening Exclusion Criteria Details Exclusion Criteria: Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized 1.DUs due to condition other than SSc. 2.Symptomatic pulmonary arterial hypertension (PAH). 3.Body mass index (BMI: kg/m2) less than Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal (ULN). 5.Hemoglobin less than 75 percent of the lower limit of the normal range. 6.Systolic blood pressure less than 95 mmhg or diastolic blood pressure less than 50mmHg. 7.Severe malabsorption, any severe organ failure (e.g., lung, kidney), or any life-threatening condition. 8.Comorbidities, other than SSc, that could seriously affect the assessment of hand function. 9.Females who are pregnant or breastfeeding or plan to do so during the course of this study. 10.Substance or alcohol abuse or dependence, or tobacco use. 11.Treatment with PDE5 inhibitors (e.g., sildenafil, tadalafil). 12.Patients on statins (e.g., atorvastatin, simvastatin), who have received treatment for less than 3 months prior to Screening (Visit 1) or whose treatment has not been stable during this period. 13.Patients on vasodilators, N-acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment for less than 2 weeks prior to Screening (Visit 1) or whose treatment has not been stable during this period. 14.Treatment with prostanoids. 15.Treatment with disease modifying agents such as methotrexate and cyclophosphamide if present for less than 3 months prior to Screening (Visit 1) or whose treatment has not been stable for at least 1 month prior to Screening (Visit 1). Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Cumulative number of new ulcers on the finger. Cumulative number of new ulcers on the finger. Secondary Outcome Outcome Timepoints Not applicable Not applicable page 4 / 5

5 Powered by TCPDF ( PDF of Trial Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=285 Sample Size from =24 25/05/ /01/2012 Years=2 Months=8 Days=0 Completed Completed Not applicable. The study is a randomized, placebo-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. The patients would be randomized into either the Macitentan 3mg q.d or macitenatn 10mg q.d or placebo q.d arm with the upper limit of treatment duration expected to be about 25 months. The study would be conducted in three centers in with the other participating countries being Australia, Belarus, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Russia, Ukraine and United States. The primary outcome would be to assess the cumulative number of new DUs up to Week 16. The enrollment in is anticipated to start by 4 May page 5 / 5