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 18 months of treatment. Secondary endpoints include the change in LVMI by MRI at Treatment Month 9 and 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 Months 9 and 18. Composite outcomes and individual event data will also be evaluated by treatment group.

Condition	Treatment or Intervention	Phase
Hypertension Left Ventricular Hypertrophy	Drug: carvedilol modified release	Phase III

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Stage 1 or Stage 2 hypertension
• Left ventricular hypertrophy

Exclusion criteria:

• in atrial fibrillation
• takes beta-blocker for MI (myocardial infarction) or arrhythmia
• has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary disease), liver or kidney disease
• uses beta-2-agonists
• unable to undergo MRI (magnetic resonance imaging)

Alabama
      Birmingham,  Alabama,  35294,  United States; Recruiting
      Mobile,  Alabama,  36608,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85020,  United States; Recruiting
      Chandler,  Arizona,  85224,  United States; Recruiting
      Sun City,  Arizona,  85351,  United States; Recruiting
      Peoria,  Arizona,  85381,  United States; Recruiting
Arkansas
      Little Rock,  Arkansas,  72211,  United States; Not yet recruiting
California
      Los Angeles,  California,  90033,  United States; Not yet recruiting
      Los Angeles,  California,  90048,  United States; Recruiting
      Los Angeles,  California,  90095,  United States; Not yet recruiting
      San Diego,  California,  92128,  United States; Not yet recruiting
      Santa Ana,  California,  92705,  United States; Recruiting
      Los Banos,  California,  93635,  United States; Recruiting
      Palo Alto,  California,  94301,  United States; Recruiting
Colorado
      Denver,  Colorado,  80204,  United States; Recruiting
      Denver,  Colorado,  80218,  United States; Recruiting
      Denver,  Colorado,  80262,  United States; Not yet recruiting
      Colorado Springs,  Colorado,  80907,  United States; Recruiting
      Colorado Springs,  Colorado,  80907,  United States; Recruiting
Delaware
      Newark,  Delaware,  19718,  United States; Not yet recruiting
District of Columbia
      Washington,  District of Columbia,  20010,  United States; Not yet recruiting
Florida
      Jacksonville,  Florida,  32209,  United States; Recruiting
      Pembroke Pines,  Florida,  33029,  United States; Recruiting
      Miami,  Florida,  33156,  United States; Recruiting
      Atlantis,  Florida,  33462,  United States; Recruiting
Georgia
      Atlanta,  Georgia,  30303,  United States; Not yet recruiting
Illinois
      Evanston,  Illinois,  60201,  United States; Recruiting
      Chicago,  Illinois,  60611,  United States; Not yet recruiting
Indiana
      Fort Wayne,  Indiana,  46804,  United States; Recruiting
Maine
      Scarborough,  Maine,  04074,  United States; Recruiting
Maryland
      Columbia,  Maryland,  21044,  United States; Recruiting
      Baltimore,  Maryland,  21215,  United States; Recruiting
      Baltimore,  Maryland,  21224,  United States; Recruiting
      Annapolis,  Maryland,  21401,  United States; Not yet recruiting
Michigan
      Grand Rapids,  Michigan,  49503,  United States; Not yet recruiting
Minnesota
      Minneapolis,  Minnesota,  55417,  United States; Recruiting
      Edina,  Minnesota,  55435,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Not yet recruiting
New Jersey
      Newark,  New Jersey,  07112,  United States; Not yet recruiting
      Camden,  New Jersey,  08103,  United States; Recruiting
      Lawrenceville,  New Jersey,  08648,  United States; Not yet recruiting
      New Brunswick,  New Jersey,  08901,  United States; Not yet recruiting
New York
      New York,  New York,  10003,  United States; Not yet recruiting
      New York,  New York,  10021,  United States; Recruiting
      New York,  New York,  10128,  United States; Recruiting
      Williamsville,  New York,  14221,  United States; Recruiting
North Carolina
      Greensboro,  North Carolina,  27401,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  45267,  United States; Not yet recruiting
Oregon
      Eugene,  Oregon,  97401,  United States; Not yet recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
      Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
      Doylestown,  Pennsylvania,  18901,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
      West Grove,  Pennsylvania,  19390,  United States; Recruiting
South Carolina
      Columbia,  South Carolina,  29204,  United States; Recruiting
      Greer,  South Carolina,  29651,  United States; Not yet recruiting
Tennessee
      Nashville,  Tennessee,  37205,  United States; Recruiting
      Kingsport,  Tennessee,  37660,  United States; Not yet recruiting
Texas
      Houston,  Texas,  77030,  United States; Recruiting
      Amarillo,  Texas,  79106,  United States; Not yet recruiting
Virginia
      Roanoke,  Virginia,  24014,  United States; Recruiting
      Danville,  Virginia,  24541,  United States; Recruiting
Wisconsin
      Milwaukee,  Wisconsin,  53215,  United States; Not yet recruiting

Study ID Numbers:  COR100216
Record last reviewed:  April 2005
Last Updated:  April 13, 2005
Record first received:  April 13, 2005
ClinicalTrials.gov Identifier:  NCT00108082
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-14