Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01302444
Status:
TERMINATED
Last Update Posted:
2013-07-26
First Post:
2011-02-16
Brief Title:
Treprostinil Combined With Tadalafil for Pulmonary Hypertension
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Randomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
One subject enrolled and completed this study The study was stopped due to poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T2
Brief Summary:
Objectives To test whether the combined administration of the medications treprostinila prostacycline therapy and tadalafila PDE-5 phosphodiesterase type 5Inhibitor therapy is better than the administration of treprostinil alone This treatment would be offered to newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for this disease and are deemed candidates for the medication treprostinil by their physician The combination therapy will be compared to single therapy with only treprostinil in a double-blind manner
Current therapy is to begin one treatment either a PDE5 inhibitor or a prostacycline depending on the severity of the patients PAH pulmonary arterial hypertension disease and add additional therapies as deterioration occurs This treatment could add two agents initially
Secondary objectives are To improve pulmonary arterial pressures as measured through a cardiac echocardiogram improve the subjects 6minute walk distance delaying the time to clinical worsening and lowering plasma BNP levels
Research Procedures To begin the administration of both treatments at the same time
Time period is 16 weeks with a one- year follow-up Cardiac Echocardiograms clinic physician exams and lab work will be followed Subjects will be between the ages of 18 - 75
Current therapy is to begin one treatment either a PDE5 inhibitor or a prostacycline depending on the severity of the patients PAH pulmonary arterial hypertension disease and add additional therapies as deterioration occurs This treatment could add two agents initially
Secondary objectives are To improve pulmonary arterial pressures as measured through a cardiac echocardiogram improve the subjects 6minute walk distance delaying the time to clinical worsening and lowering plasma BNP levels
Research Procedures To begin the administration of both treatments at the same time
Time period is 16 weeks with a one- year follow-up Cardiac Echocardiograms clinic physician exams and lab work will be followed Subjects will be between the ages of 18 - 75
Detailed Description:
Background Many cardiovascular diseases such as essential hypertension coronary artery disease and congestive heart failure respond better to combinations of vasoactive drugs than to therapy with a single agent Three categories of pulmonary anti-hypertensive medications have been developed over the last 20 years but their effect on management of PAH when used in combination are mostly unknown Two of the pulmonary arterial hypertension PAH drug groups are prostacyclines and PDE5 inhibitors Although the effects of prostacyclins are mediated via cAMP cyclic guanosine monophosphate and the effects of PDE5 inhibitors are mediated via cGMP there is considerable cross talk between these nucleotides suggesting that adequate levels of both may be needed to maintain normal pulmonary vascular tone and cellular growth responses
ObjectiveHypothesis This proposal hypothesizes that increasing the levels of both nucleotides prostacyclines and PDE5 inhibitors may be more efficacious in the treatment of PAH than increasing either one alone
Specific Aims The primary objective of this study is to determine if the combination of treprostinil infusion combined with tadalafil is more efficacious than treprostinil alone in improving the change from baseline in the 6 minute walking distance after 16 weeks of therapy
Study Design The proposed study is a multi-center randomized double blind two cohort parallel group and 16-week study with 1-year long-term follow-up The study aims to compare the efficacy of combination therapy with treprostinil infusion and tadalafil to treprostinil infusion alone
Study Population All patients who have been newly diagnosed with PAH and who after consultation with their physician have elected to be treated with treprostinil infusion will be invited to participate A total of 66 subjects will be sort to enroll
Treprostinil dosing will follow a 4 week up-titration schedule with a target 4week dose of 8ngkgmin minimum followed by a 12 week randomized tadalafil period
ObjectiveHypothesis This proposal hypothesizes that increasing the levels of both nucleotides prostacyclines and PDE5 inhibitors may be more efficacious in the treatment of PAH than increasing either one alone
Specific Aims The primary objective of this study is to determine if the combination of treprostinil infusion combined with tadalafil is more efficacious than treprostinil alone in improving the change from baseline in the 6 minute walking distance after 16 weeks of therapy
Study Design The proposed study is a multi-center randomized double blind two cohort parallel group and 16-week study with 1-year long-term follow-up The study aims to compare the efficacy of combination therapy with treprostinil infusion and tadalafil to treprostinil infusion alone
Study Population All patients who have been newly diagnosed with PAH and who after consultation with their physician have elected to be treated with treprostinil infusion will be invited to participate A total of 66 subjects will be sort to enroll
Treprostinil dosing will follow a 4 week up-titration schedule with a target 4week dose of 8ngkgmin minimum followed by a 12 week randomized tadalafil period
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