Ignite Creation Date:
2024-05-05 @ 11:18 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01305252
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2010-11-02
Brief Title:
A 48-week Study of the Effect of Dual Therapy Inhaled Treprostinil and Tadafafil Versus Monotherapy Tadalafil
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
CombinatiON Up-FRON t Therapy for PAH - A Phase 4 Randomized Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on Tadalafil
Status:
COMPLETED
Status Verified Date:
2017-04
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:
None
Brief Summary:
The Study Hypothesis
Aggressive upfront dual therapy for treatment-naïve NYHA IIIIII PAH is superior to a traditional step-up approach
The study will evaluate
1 Impact of dual upfront therapy on cardiovascular parameters in PAH as gauged by cardiac magnetic resonance imaging cMRI at 24 weeks and event free survival at outcome at 48 weeks
2 Value of novel biomarkers NT-pro BNP Mts1S100A4 and insulin resistance and cutting-edge imaging technologies cardiac MRI as newer endpoints for clinical trials in PAH
3 Utility of longer clinical trial design with the use of combined clinical events as time to clinical worsening surrogate
Aggressive upfront dual therapy for treatment-naïve NYHA IIIIII PAH is superior to a traditional step-up approach
The study will evaluate
1 Impact of dual upfront therapy on cardiovascular parameters in PAH as gauged by cardiac magnetic resonance imaging cMRI at 24 weeks and event free survival at outcome at 48 weeks
2 Value of novel biomarkers NT-pro BNP Mts1S100A4 and insulin resistance and cutting-edge imaging technologies cardiac MRI as newer endpoints for clinical trials in PAH
3 Utility of longer clinical trial design with the use of combined clinical events as time to clinical worsening surrogate
Detailed Description:
This is a 48 week interventional study evaluating the effect of Dual therapy Treprostinil inhalations and Tadalafil versus Mono therapy Tadalafil The impact of the therapy on cardiovascular parameters in PAH measured at 24 weeks and event free survival outcome at 48 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB protocol 18305 | None | None | None |