Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT03809156
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upfront Combination Pulmonary Arterial Hypertension Therapy
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
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:
None
Brief Summary:
To evaluate the safety and efficacy of first-line combination therapy using riociguat with ambrisentan in patients with Pulmonary Arterial Hypertension (PAH).
Detailed Description:
This is a prospective, multi-center, open-label, exploratory study with patients followed for a period of one year. The treatment duration period in this study begins at the initiation of ambrisentan plus riociguat and will continue for 12 months. Patients will come to clinic for a visit at month 4 and 12. Assessments will include Right Heart Catheterization, 6 Minute walk test, cardiac MRI, questionnaires and nt-Pro-BNP.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: