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Trial record 1 of 1 for:    NCT02260557
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Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT02260557
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Secondary to Systemic Sclerosis Drug: Selexipag Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Selexipag

Arm Intervention/treatment
Experimental: Selexipag
Selexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD.
Drug: Selexipag
Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
Other Name: ACT-293987

Experimental: Placebo
Placebo matching selexipag tablets is administered according to the same schedule as selexipag
Drug: Placebo
Placebo matching selexipag 200 μg tablets to be administered orally twice daily




Primary Outcome Measures :
  1. Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period [ Time Frame: From Day 26 to Day 56 ( +/- 7 days) ]
    The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).


Secondary Outcome Measures :
  1. Number of patients with treatment-emergent adverse events [ Time Frame: Up to end of study (Day 86 +/- 7 days) ]
    A treatment-emergent adverse event is any adverse event (AE) temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests

  2. Number of patients with treatment-emergent serious adverse events [ Time Frame: Up to end of study (Day 86 +/- 7 days) ]

Other Outcome Measures:
  1. Change from baseline in quality of life (QOL) [ Time Frame: At baseline (Day 1) and end of treatment (Day 56 +/- 7 days) ]
    QOL is assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
  • Women of childbearing potential must agree to use a reliable method of birth control.

Key exclusion criteria:

  • Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
  • Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
  • Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
  • Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
  • Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
  • Severe renal insufficiency (at randomization).
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260557


Locations
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France
Investigator Site
Grenoble cedex, France, 38043
Investigator Site
Lille Cedex, France, 59037
Investigator Site
Nantes Cedex 1, France, 44093
Investigator Site
Paris, France, 75679
Investigator Site
Strasbourg, France, 67200
Germany
Investigator Site
Bad Nauheim, Germany, 61231
Investigator Site
Berlin, Germany, 10117
Investigator Site
Erlangen, Germany, 91054
Investigator Site
Koln, Germany, 50937
Investigator Site
Magdeburg, Germany, 39120
Investigator Site
Mainz, Germany, 55131
United Kingdom
Investigator Site
Bath, United Kingdom, BA11RL
Investigator Site
Leeds, United Kingdom, LS74SA
Investigator Site
Liverpool, United Kingdom, L97AL
Investigator Site
London, United Kingdom, NW32QG
Investigator Site
Salford, United Kingdom, M55AP
Sponsors and Collaborators
Actelion
Investigators
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Study Chair: Ralph Preiss, MD Actelion

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02260557    
Other Study ID Numbers: AC-065C202
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Keywords provided by Actelion:
Systemic Sclerosis
Raynaud's Phenomenon
Additional relevant MeSH terms:
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Neoplasm Metastasis
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Neoplastic Processes
Neoplasms
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Selexipag
Antihypertensive Agents