Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050076
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2002-11-20
Brief Title:
Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase II Double-Blind Randomized Exploratory Placebo-Controlled Study of Efficacy Safety and Tolerability of MCC-135 Comparing QD vs BID Doses in Subjects With Congestive Heart Failure NYHA Class IIIII
Status:
COMPLETED
Status Verified Date:
2012-01
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 determine the effect of two different doses of MCC-135 once daily QD or twice daily BID on the disease state and the quality of life in subjects with congestive heart failure
Detailed Description:
In recent years the usefulness of angiotensin converting enzyme inhibitors and vasodilators as well as beta-blockers has been realized in the treatment of heart failure Multi-center studies clinical trials have shown some benefit of angiotensin converting enzyme inhibitors on the morbidity and mortality of heart failure subjects and physicians are also prescribing angiotensin converting enzyme inhibitors for the initial treatment of subjects with left ventricular dysfunction Some subjects do not respond to angiotensin converting enzyme inhibitors and intolerance to these compounds has also been observed Despite the significant reduction in mortality observed in limited controlled studies the 5-year mortality of subjects with congestive heart failure continues to be high indicating that there is a significant therapeutic gap in the treatment of this disease
MCC-135 is being studied to assess its usefulness as a supplement or replacement to current treatment and to provide subjects with specific and predictable therapy that will reverse the remodeling of the diseased heart and markedly improve the subjects survival The current study is an exploratory clinical trial to determine the efficacy of two doses and two dose regimens of MCC-135 when compared to placebo by evaluating improvement in the subjects plasma b-type brain natriuretic peptide levels regular rate heart rate variability and clinical signs and symptoms
MCC-135 is being studied to assess its usefulness as a supplement or replacement to current treatment and to provide subjects with specific and predictable therapy that will reverse the remodeling of the diseased heart and markedly improve the subjects survival The current study is an exploratory clinical trial to determine the efficacy of two doses and two dose regimens of MCC-135 when compared to placebo by evaluating improvement in the subjects plasma b-type brain natriuretic peptide levels regular rate heart rate variability and clinical signs and symptoms
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 |
|---|---|---|---|
| U1111-1127-6077 | REGISTRY | WHO | None |