Trial · NCT01474109

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

NCT01474109, Phase 3, Completed, Actelion; results first posted 2015-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients. Trials, record NCT01474109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01474109

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
NCT number: NCT01474109
Status: Completed
Phases: Phase 3
Enrollment: 289 participants, actual
Lead sponsor: Actelion
Conditions: Systemic Sclerosis, Ulcers
Interventions: macitentan 3mg, macitentan 10mg, placebo
First posted: 2011-11-18
Last updated: 2015-01-06
Results first posted: 2015-01-06

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence Rate of New Digital Ulcers (DUs) up to Week 16	Baseline to week 16	DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.
Secondary	Percentage of Participants Without a New DU Up To Week 16	Baseline to week 16	DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.
Secondary	Percentage of Participants With at Least One DU Complication	Up to approximately 90 weeks	DU complications were defined as any one of the following, resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a \> 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.
Secondary	Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16	Baseline to week 16	HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).
Secondary	Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16	Baseline to week 16	HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).
Secondary	Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16	Baseline to week 16	Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence Rate of New Digital Ulcers (DUs) up to Week 16	Baseline to week 16	Full analysis set	number of new DUs/observation days	NUMBER
SECONDARY	Percentage of Participants Without a New DU Up To Week 16	Baseline to week 16	Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With at Least One DU Complication	Up to approximately 90 weeks	Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.	percentage of participants	NUMBER
SECONDARY	Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16	Baseline to week 16	Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.	units on a scale	MEAN
SECONDARY	Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16	Baseline to week 16	Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.	units on a scale	MEAN
SECONDARY	Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16	Baseline to week 16	Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Incidence Rate of New Digital Ulcers (DUs) up to Week 16	Macitentan 3mg		0.9082		number of new DUs/observation days
Incidence Rate of New Digital Ulcers (DUs) up to Week 16	Macitentan 10mg		0.9567		number of new DUs/observation days
Incidence Rate of New Digital Ulcers (DUs) up to Week 16	Placebo		0.8115		number of new DUs/observation days
Percentage of Participants Without a New DU Up To Week 16	Macitentan 3mg		64.1		Percentage of participants
Percentage of Participants Without a New DU Up To Week 16	Macitentan 10mg		63.0		Percentage of participants
Percentage of Participants Without a New DU Up To Week 16	Placebo		67.0		Percentage of participants
Percentage of Participants With at Least One DU Complication	Macitentan 3mg		14.1		percentage of participants
Percentage of Participants With at Least One DU Complication	Macitentan 10mg		19.6		percentage of participants
Percentage of Participants With at Least One DU Complication	Placebo		19.1		percentage of participants
Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16	Macitentan 3mg	Baseline	1.3	Standard Deviation 0.73	units on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1: Baseline to Week 16	STARTED	Macitentan 3mg	95
Period 1: Baseline to Week 16	STARTED	Macitentan 10mg	97
Period 1: Baseline to Week 16	STARTED	Placebo	97
Period 1: Baseline to Week 16	COMPLETED	Macitentan 3mg	88
Period 1: Baseline to Week 16	COMPLETED	Macitentan 10mg	91
Period 1: Baseline to Week 16	COMPLETED	Placebo	95
Period 1: Baseline to Week 16	NOT COMPLETED	Macitentan 3mg	7
Period 1: Baseline to Week 16	NOT COMPLETED	Macitentan 10mg	6
Period 1: Baseline to Week 16	NOT COMPLETED	Placebo	2
Period 2: Week 16 to End of Study	STARTED	Macitentan 3mg	88

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events276

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	HEADACHE	Nervous system disorders	Macitentan 3mg	14	94
other	HEADACHE	Nervous system disorders	Macitentan 10mg	19	97
other	HEADACHE	Nervous system disorders	Placebo	12	97
other	INFECTED SKIN ULCER	Infections and infestations	Macitentan 3mg	7	94
other	INFECTED SKIN ULCER	Infections and infestations	Macitentan 10mg	12	97
other	INFECTED SKIN ULCER	Infections and infestations	Placebo	11	97
other	OEDEMA PERIPHERAL	General disorders	Macitentan 3mg	7	94
other	OEDEMA PERIPHERAL	General disorders	Macitentan 10mg	12	97
other	OEDEMA PERIPHERAL	General disorders	Placebo	6	97
other	SKIN ULCER	Skin and subcutaneous tissue disorders	Macitentan 3mg	6	94

1 to 10 of 276Source ClinicalTrials.gov

See all 276 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Macitentan 3mg
Total, all-cause mortality	Macitentan 10mg
Total, all-cause mortality	Placebo
Total, other adverse events	Macitentan 3mg	61	94
Total, other adverse events	Macitentan 10mg	73	97
Total, other adverse events	Placebo	69	97
Total, serious adverse events	Macitentan 3mg	17	94
Total, serious adverse events	Macitentan 10mg	14	97
Total, serious adverse events	Placebo	13	97

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27163986	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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