Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following screening, 413 participants were enrolled into the study to begin an open-label run-in phase with lisinopril 10 mg once daily (OD) for 1 week and then lisinopril 20 mg OD for 1 week. Of these participants, 287 were randomized to 1 of the 3 treatment regimens.

Reporting Groups

	Description
Carvedilol CR	Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
Atenolol	Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
Lisinopril	Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.

Participant Flow:   Overall Study

	Carvedilol CR	Atenolol	Lisinopril
STARTED	91	100	96
COMPLETED	53 [1]	68 [1]	53 [1]
NOT COMPLETED	38	32	43
Adverse Event	14	12	17
Lost to Follow-up	6	3	7
Consent Withdrawn	3	3	5
Protocol Violation	1	2	0
Lack of Efficacy	3	1	2
Amendment 4: > Month 12	5	7	5
Woman of Child-bearing Potential	2	0	2
Incorrectly Randomized	0	0	2
Non-compliance	1	0	2
Stopped Study Medication	0	0	1
Site Closed Study	0	2	0
Protocol Amendment	0	1	0
Study Medication Not Tapered	0	1	0
Subject Left Site Location	1	0	0
Investigator Not at Site	1	0	0
Blood Pressure Not Controlled	1	0	0

Reporting Groups

	Description
Carvedilol CR	Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
Atenolol	Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
Lisinopril	Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.

Baseline Measures

	Carvedilol CR	Atenolol	Lisinopril	Total
Number of Participants   [units: participants]	91	100	96	287
Age   [units: years] Mean ± Standard Deviation	56.6  ± 10.53	57.4  ± 10.95	55.9  ± 10.09	56.7  ± 10.52
Gender   [units: participants]
Female	40	41	47	128
Male	51	59	49	159
Race/Ethnicity, Customized   [units: participants]
African American/African Heritage	17	26	17	60
American Indian/Alaska Native	0	1	1	2
Asian	2	1	0	3
White/Caucasian	67	67	72	206
Arabic/North African Heritage	1	0	1	2
Mixed Race	1	0	1	2
Not Reported	3	5	4	12

1.  Primary:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

2.  Secondary:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

3.  Secondary:

Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

4.  Secondary:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

5.  Secondary:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available) ]

6.  Secondary:

Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

7.  Secondary:

Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

8.  Secondary:

Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

9.  Secondary:

Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

10.  Secondary:

Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ]

11.  Secondary:

Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used ]

12.  Secondary:

Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used) ]

13.  Secondary:

Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used) ]

14.  Secondary:

Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12   [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used) ]