Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03904693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2019-04-04
Brief Title:
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension PAH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Prospective Multi-center Double-blind Randomized Active-controlled Triple-dummy Parallel-group Group-sequential Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension PAH Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
A DUE
Brief Summary:
Combination therapy in pulmonary arterial hypertension PAH has been the subject of active investigation for more than a decade with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease Adherence to prescribed therapy has an impact on clinical outcomes Reducing the pilltablet count and frequency has a major impact on patients adherence to therapies and therefore the observed clinical outcomes One way to simplify treatment is to use fixed-dose combination FDC products that combine multiple treatments targeting different pathways into a single tablet
This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC macitentan 10 mg and tadalafil 40 mg against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC
This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC macitentan 10 mg and tadalafil 40 mg against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC
Detailed Description:
PAH is characterized by a progressive increase in pulmonary arterial pressure PAP and in pulmonary vascular resistance PVR potentially leading to right heart failure and death Current PAH-specific therapeutic options include treatments that target the three pathways endothelin nitric oxide and prostacyclin pathways While combination treatment is common FDC pills or tablets that combine two or more PAH-specific therapies are not available thereby requiring participants to take multiple pillstablets daily An FDC is an attractive option for PAH participants because it simplifies the treatment regimen by combining two therapies which would otherwise involve a total of three tablets one macitentan 10 mg tablet and two tadalafil 20 mg tablets into a single tablet Macitentan is an orally active non-peptide potent dual endothelin receptor A and B antagonist Tadalafil is a selective inhibitor of phosphodiesterase type-5 PDE-5 the enzyme responsible for the degradation of cyclic guanosine monophosphate cGMP This study comprises the following consecutive periods Screening period lasts up to 30 days Double-blind treatment period consists of the titration phase the first 2 weeks and the maintenance phase Week 3 through Week 16 Open-label treatment period End-of-Treatment EOT Safety follow-up S-FU period and End of Study EOS The total study duration for a participant will be up to 30 months Study assessments like physical examinations vital signs right heart catheterization 6-minute walk test will be performed Safety will be assessed throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AC-077A301 | OTHER | Actelion Pharmaceuticals Ltd | None |
| 2014-004786-25 | EUDRACT_NUMBER | None | None |