Trial · NCT00667823
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
NCT00667823, Phase 3, Completed, Actelion; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension. Trials, record NCT00667823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
- NCT number
- NCT00667823
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 550 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan
- First posted
- 2008-04-28
- Last updated
- 2025-03-30
- Results first posted
- 2022-02-10
- Limitations and caveats
The limitation of the open-label study design was the open label nature of the trial due to which the number of participants decreased over time to the extent that 10 percent (%) and 2.4% of participants (N=550) remained in the study at Years 7 and 9, respectively.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to 12 years) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. |
| Primary | Number of Participants With Death up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to 12 years) | Number of participants with deaths up to 28 days after study treatment discontinuation were reported. |
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to 12 years) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above. |
| Primary | Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment | Up to 28 days after study treatment discontinuation (Up to12 years) | Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Primary | Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to12 years) | Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (\>) 3\*upper limit of normal (ULN) or aspartate aminotransferase (AST) \>3\* ULN, ALT \>5\* ULN or AST \>5\*ULN, ALT \>8\*ULN or AST \>8\*ULN, total bilirubin (TBIL) \>2\*ULN, ALT \>3\*ULN or AST \>3\*ULN and TBIL \>2\*ULN at any time were reported. |
| Primary | Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation | Up to 28 days after treatment discontinuation (Up to 12 years) | Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were \<=80 grams/Liter (g/L), \<=100g/L, decrease from baseline \>=20 g/L, and decrease from baseline \>=50 g/L. |
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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to 12 years) | The safety analysis set (SAF) included all participants who received at least 1 dose of macitentan 10 milligrams (mg). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Death up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to 12 years) | The SAF included all participants who received at least 1 dose of macitentan 10 mg. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to 12 years) | The SAF included all participants who received at least 1 dose of macitentan 10 mg. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment | Up to 28 days after study treatment discontinuation (Up to12 years) | The safety analysis set (SAF) included all participants who received at least 1 dose of macitentan 10 mg. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Up to 28 days after study treatment discontinuation (Up to12 years) | The SAF included all participants who received at least 1 dose of macitentan 10 mg. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation | Up to 28 days after treatment discontinuation (Up to 12 years) | The SAF included all participants who received at least 1 dose of macitentan 10 mg. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | 527 | Participants | ||
| Number of Participants With Death up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | 175 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | 354 | Participants | ||
| Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment | Macitentan 10 mg | 62 | Participants | ||
| Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | ALT or AST >3*ULN | 45 | Participants | |
| Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | ALT or AST >5*ULN | 20 | Participants | |
| Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | ALT or AST >8*ULN | 11 | Participants | |
| Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | TBIL >2*ULN | 75 | Participants | |
| Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | ALT or AST >3*ULN and (TBIL>2*ULN at any time) | 8 | Participants | |
| Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation | Macitentan 10 mg | HGB <= 80 gram/Liter (g/L) | 33 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan 10 mg | 550 | |
| Overall Study | COMPLETED | Macitentan 10 mg | 334 | |
| Overall Study | NOT COMPLETED | Macitentan 10 mg | 216 |
Source ClinicalTrials.gov
Adverse events392
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Macitentan 10 mg | 80 | 550 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Macitentan 10 mg | 14 | 550 | |
| other | Leukopenia | Blood and lymphatic system disorders | Macitentan 10 mg | 22 | 550 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Macitentan 10 mg | 36 | 550 | |
| other | Atrial Fibrillation | Cardiac disorders | Macitentan 10 mg | 24 | 550 | |
| other | Palpitations | Cardiac disorders | Macitentan 10 mg | 34 | 550 | |
| other | Right Ventricular Failure | Cardiac disorders | Macitentan 10 mg | 24 | 550 | |
| other | Tachycardia | Cardiac disorders | Macitentan 10 mg | 22 | 550 | |
| other | Hypothyroidism | Endocrine disorders | Macitentan 10 mg | 21 | 550 | |
| other | Abdominal Distension | Gastrointestinal disorders | Macitentan 10 mg | 14 | 550 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan 10 mg | 182 | 550 |
| Total, other adverse events | Macitentan 10 mg | 476 | 550 |
| Total, serious adverse events | Macitentan 10 mg | 354 | 550 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT00667823
GET https://conductscience.org/api/trials/v1/NCT00667823/events?page=2