Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108082
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2005-04-13
Brief Title:
The CLEVER Study - Coreg And Left Ventricular Mass Regression
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Multi-Center Study Comparing the Effects of Carvedilol Modified Release Formulation COREG MR and Atenolol in Combination With and Compared to an Angiotensin Converting Enzyme Inhibitor Lisinopril on Left Ventricular Mass Regression in Hypertensive Patients With Left Ventricular Hypertrophy LVH
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This study is designed to compare the effects of COREG MR carvedilol modified release formulation to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme ACE inhibition and to the effect of ACE inhibition alone Subjects with LVH left ventricular hypertrophy and hypertension will be studied The primary endpoint will be the change in left ventricular mass index LVMI characterized by magnetic resonance imaging MRI following 12 months of treatment Secondary endpoints include the change in LV left ventricular mass LV wall thickness diastolic left ventricular filling parameters and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12 Composite outcomes and individual event data will also be evaluated by treatment group
Detailed Description:
A Randomized Double-Blind Multi-Center Study Comparing the Effects of Carvedilol Modified Release Formulation COREG MR and Atenolol in Combination with and Compared to an Angiotensin Converting Enzyme Inhibitor Lisinopril on Left Ventricular Mass Regression in Hypertensive Patients with Left Ventricular Hypertrophy LVH
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