Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103519
Status:
TERMINATED
Last Update Posted:
2013-03-29
First Post:
2005-02-09
Brief Title:
Study of DITPA in Patients With Congestive Heart Failure
Sponsor:
Titan Pharmaceuticals
Organization:
Titan Pharmaceuticals
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study of DITPA in Patients With NYHA Class III and IV Congestive Heart Failure Who Have Low Serum T3 Levels
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated for reasons unrelated to safety or efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the safety and efficacy of DITPA relative to placebo in patients with New York Heart Association NYHA class III or IV congestive heart failure CHF who have low serum T3 DITPA is an investigational agent
Detailed Description:
Rationale Congestive heart failure CHF is a major public health problem associated with significant morbidity and mortality in patients with New York Heart Association NYHA class III or IV disease Multiple studies have identified a particularly high-risk group of patients who have reduced thyroid hormone activity specifically low serum triiodothyronine T3 levels This group represents approximately 30 of patients with NYHA class III or IV disease and has significantly higher mortality rates than those with normal T3
DITPA 35-diiodothyropropionic acid is an analogue of naturally occurring thyroid hormone T3 that has been specifically designed to improve cardiac performance with a lower potential for tachycardia in CHF patients Although structurally similar to T3 DITPA has a propionic acid side chain and lacks an iodine at the 3 position of the outer phenolic ring While DITPA binds to the same thyroid hormone receptors as T3 binding affinities are significantly less suggesting partial agonistic actions Preclinical studies with DITPA have supported a rationale for its use in patients with CHF
Primary objective To assess the safety and tolerability of DITPA in patients with NYHA class IIIIV CHF and low serum T3
Secondary Objective To obtain preliminary evidence of the efficacy of DITPA in patients with NYHA class IIIIV CHF and low serum T3
Design The multi-center randomized double-blind placebo-controlled study is designed to evaluate the safety and tolerability of DITPA in patients with NYHA class III or IV CHF who have low levels of serum T3 with normal levels of thyroid stimulating hormone TSH
One hundred and fifty patients at approximately 35 centers in the US will be randomized to 1 of 3 treatment groups in a 111 ratio ie 50 patients per treatment group
DITPA at 180 mgday 90 mg twice a day BID orally
DITPA at 360 mgday 180 mg BID orally
Placebo BID orally
DITPA 35-diiodothyropropionic acid is an analogue of naturally occurring thyroid hormone T3 that has been specifically designed to improve cardiac performance with a lower potential for tachycardia in CHF patients Although structurally similar to T3 DITPA has a propionic acid side chain and lacks an iodine at the 3 position of the outer phenolic ring While DITPA binds to the same thyroid hormone receptors as T3 binding affinities are significantly less suggesting partial agonistic actions Preclinical studies with DITPA have supported a rationale for its use in patients with CHF
Primary objective To assess the safety and tolerability of DITPA in patients with NYHA class IIIIV CHF and low serum T3
Secondary Objective To obtain preliminary evidence of the efficacy of DITPA in patients with NYHA class IIIIV CHF and low serum T3
Design The multi-center randomized double-blind placebo-controlled study is designed to evaluate the safety and tolerability of DITPA in patients with NYHA class III or IV CHF who have low levels of serum T3 with normal levels of thyroid stimulating hormone TSH
One hundred and fifty patients at approximately 35 centers in the US will be randomized to 1 of 3 treatment groups in a 111 ratio ie 50 patients per treatment group
DITPA at 180 mgday 90 mg twice a day BID orally
DITPA at 360 mgday 180 mg BID orally
Placebo BID orally
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