Trials / Terminated
TerminatedNCT02968901
Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to document the effect of first line dual oral combination therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | macitentan | used in open label |
| DRUG | tadalafil | used in open label |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2018-09-10
- Completion
- 2018-09-10
- First posted
- 2016-11-21
- Last updated
- 2019-10-08
Locations
18 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02968901. Inclusion in this directory is not an endorsement.