Viewing Study NCT02968901



Ignite Creation Date: 2024-05-06 @ 9:21 AM
Last Modification Date: 2024-10-26 @ 12:13 PM
Study NCT ID: NCT02968901
Status: TERMINATED
Last Update Posted: 2019-10-08
First Post: 2016-11-14

Brief 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
Sponsor: Actelion
Organization: Actelion

Study Overview

Official Title: 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
Status Verified Date: 2019-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: OPTIMA
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None