Trial · NCT02968901
Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
NCT02968901, Phase 4, Terminated, Actelion
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA). Trials, record NCT02968901. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02968901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
- NCT number
- NCT02968901
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 46 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- macitentan, tadalafil
- First posted
- 2016-11-21
- Last updated
- 2019-10-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pulmonary vascular resistance (PVR) | 16 weeks | Change from Baseline to Week 16 in percentage of patients with clinically meaningful improvement of PVR (decrease of 30% from baseline to Week 16) |
| Secondary | mean right atrial pressure (mRAP) | Week 16 | Change from Baseline to Week 16 in mean right atrial pressure (mRAP) |
| Secondary | 6MWD | Week 16 | Change from Baseline to Week 16 in 6MWD |
| Secondary | level NT-proBNP | Week 16 | Change in NT-proBNP from baseline to Week 16 |
| Secondary | mean pulmonary arterial pressure (mPAP) | Week 16 | Change from Baseline to Week 16 in mean pulmonary arterial pressure (mPAP) |
| Secondary | cardiac index (CI) | Week 16 | Change from Baseline to Week 16 in cardiac index (CI). |
| Secondary | total pulmonary resistance (TPR) | Week 16 | Change from Baseline to Week 16 in total pulmonary resistance (TPR) |
| Secondary | mixed venous oxygen saturation (Sv02) | Week 16 | Change from Baseline to Week 16 in mixed venous oxygen saturation (Sv02) |
| Secondary | WHO functional class | Week 16 | Change from baseline to Week 16 in WHO functional class and Percentage of patients with improvement/worsening of WHO functional class from baseline to Week 16 |
| Secondary | Number of treatment goals | Week 16 | Number of treatment goals (score 0 or 1 per goal, i.e. total score 0-5) met at Week 16: WHO-FC I or II; Cardiac index \> 2.8 L/min/m²; mRAP \< 8 mmHg; 6MWD \> 400 m; NT-proBNP \< 3xULN |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02968901
GET https://conductscience.org/api/trials/v1/NCT02968901/registered