Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01247116
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2010-11-23
Brief Title:
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension A Safety and Efficacy Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-06
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 purpose of this study is to evaluate the strategy of initiating double oral combination therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial hypertension PAH in a preliminary way
Detailed Description:
Current treatment paradigms for PAH suggest adopting goals of therapy with relatively objective parameters such as 6 minute walk distance to determine when to add a second oral agent 1 This often entails observing deterioration in the patient on a single agent before instituting the second one This strategy could be problematic as patients may never recover the function lost due to progressive PAH 2 In addition given the malignant nature of the clinical course of PAH in many cases and the nature of the underlying proliferative vasculopathy some have argued that altering this paradigm to resemble that used in cancer chemotherapy may be more appropriate 3 That is induction therapy at diagnosis with multiple agents followed by a maintenance phase of treatment might offer significant benefits to the patient
This open-label pilot study is the first to investigate the potential efficacy and safety of a first-line combination strategy in consecutive patients with PAH in contrast to the add-on strategy for combination therapy It will serve as the basis on which to consider larger multicenter investigations of this strategy
1 Hoeper M et al Eur Respir J 2005 Nov265858-63
2 Halpern SD et al Proc Am Thorac Soc 2008 Jul 1555631-5
3 Provencher S et al Chest 2005 Dec1286 Suppl622S-628S
This open-label pilot study is the first to investigate the potential efficacy and safety of a first-line combination strategy in consecutive patients with PAH in contrast to the add-on strategy for combination therapy It will serve as the basis on which to consider larger multicenter investigations of this strategy
1 Hoeper M et al Eur Respir J 2005 Nov265858-63
2 Halpern SD et al Proc Am Thorac Soc 2008 Jul 1555631-5
3 Provencher S et al Chest 2005 Dec1286 Suppl622S-628S
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