Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 45 of 116 for:    Atenolol

The CLEVER Study - Coreg And Left Ventricular Mass Regression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108082
Recruitment Status : Completed
First Posted : April 14, 2005
Results First Posted : November 9, 2009
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertrophy, Left Ventricular
Interventions Drug: carvedilol MR
Drug: atenolol
Drug: lisinopril
Enrollment 287
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description 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 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 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.
Period Title: Overall Study
Started 91 100 96
Completed 53 [1] 68 [1] 53 [1]
Not Completed 38 32 43
Reason Not Completed
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Consent Withdrawn             3             3             5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
[1]
Per protocol Amendment 4, participants who had completed Month 12 prior to amendment were withdrawn.
Arm/Group Title Carvedilol CR Atenolol Lisinopril Total
Hide Arm/Group Description 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 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 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. Total of all reporting groups
Overall Number of Baseline Participants 91 100 96 287
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 100 participants 96 participants 287 participants
56.6  (10.53) 57.4  (10.95) 55.9  (10.09) 56.7  (10.52)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 100 participants 96 participants 287 participants
Female
40
  44.0%
41
  41.0%
47
  49.0%
128
  44.6%
Male
51
  56.0%
59
  59.0%
49
  51.0%
159
  55.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 100 participants 96 participants 287 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 Outcome
Title 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
Hide Description LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 60 76 59
Mean (Standard Error)
Unit of Measure: grams per meters squared (g/m^2)
-6.34  (0.850) -6.67  (0.756) -7.94  (0.850)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carvedilol CR, Atenolol
Comments The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7651
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
-1.83 to 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Carvedilol CR, Lisinopril
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1711
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.60
Confidence Interval 95%
-0.70 to 3.90
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12
Hide Description LVMIH was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. LV mass depends on body size. One method of determining whether an individual has LV hypertrophy relates LV mass to height raised to a power of 2.7.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 60 76 59
Mean (Standard Error)
Unit of Measure: g/m raised to 2.7 (g/(m^2.7))
-3.19  (0.407) -3.37  (0.361) -3.98  (0.407)
3.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12
Hide Description LV Mass was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 60 76 59
Mean (Standard Error)
Unit of Measure: grams (g)
-13.74  (1.732) -14.17  (1.540) -17.17  (1.734)
4.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12
Hide Description LVMI was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 61 71 59
Mean (Standard Error)
Unit of Measure: grams per meters squared (g/m^2)
-20.35  (4.027) -20.06  (3.672) -18.48  (3.998)
5.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12
Hide Description LVMIH was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 61 71 59
Mean (Standard Error)
Unit of Measure: g/m raised to 2.7 (g/(m^2.7))
-11.78  (2.292) -12.51  (2.100) -11.61  (2.280)
6.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12
Hide Description LV Mass was measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 61 71 59
Mean (Standard Error)
Unit of Measure: grams
-45.76  (8.338) -40.56  (7.645) -38.58  (8.296)
7.Secondary Outcome
Title Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12
Hide Description LV filling parameters, LV E-Volume and LV A-Volume, were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. These filling parameters represent the volumes of blood filling the ventricle during the passive filling phase (E-volume) and the active filling phase caused by atrial contraction (A-volume).
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 48 54 41
Mean (Standard Error)
Unit of Measure: milliliters (mL)
LV E-volume 0.364  (2.2853) 6.763  (2.3870) -3.406  (2.8779)
LV A-volume -0.513  (1.3624) -0.565  (1.5154) 1.088  (1.5630)
8.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12
Hide Description LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. The ejection fraction is the fraction of the blood volume available at the end of diastole that is pumped out of the ventricules during systole.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 60 76 59
Mean (Standard Error)
Unit of Measure: milliliters (mL)
LV End Systolic Volume -1.44  (1.578) -4.29  (1.397) -3.04  (1.581)
LV End Diastolic Volume -2.86  (2.848) -2.45  (2.522) -7.45  (2.858)
LV Ejection Fraction 0.08  (0.685) 2.16  (0.607) -0.01  (0.685)
9.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12
Hide Description LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 60 76 59
Mean (Standard Error)
Unit of Measure: milliliters (mL)
LV End Systolic Volume -3.38  (2.067) -4.74  (1.892) -5.34  (2.086)
LV End Diastolic Volume -3.07  (3.389) -3.64  (3.108) -9.37  (3.420)
LV Ejection Fraction 1.03  (0.751) 2.33  (0.687) 0.63  (0.756)
10.Secondary Outcome
Title Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12
Hide Description Systolic and Diastolic BP were measured at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 60 76 59
Mean (Standard Error)
Unit of Measure: mmHg (millimeters of mercury)
Systolic blood pressure -21.32  (1.755) -21.12  (1.535) -22.53  (1.708)
Diastolic blood pressure -12.77  (1.103) -14.05  (0.976) -11.13  (1.117)
11.Secondary Outcome
Title Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12
Hide Description BNP concentration (picagram per milliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (mean change on log scale) -1) [Change is the Month 12 value (or value after 12 months of treatment) minus the Baseline value].
Time Frame Baseline and Month 12 (If Month 12 data were not available, the LOCF was used
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 34 42 33
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of change
51.7
(13.2 to 103.2)
48.3
(13.0 to 94.7)
-39.1
(-54.3 to -19.0)
12.Secondary Outcome
Title Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12
Hide Description CRP concentration (milligrams per deciliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent (mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]
Time Frame Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 48 66 53
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-10.63
(-27.41 to 10.02)
-3.22
(-18.82 to 15.38)
2.70
(-15.88 to 25.37)
13.Secondary Outcome
Title Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12
Hide Description Plasma lipid concentrations (milligrams per deciliter) were measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent(mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]
Time Frame Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 83 92 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of change
Total cholesterol
0.7
(-3.3 to 4.9)
-1.3
(-4.7 to 2.3)
-1.7
(-5.5 to 2.3)
Low-density lipid cholesterol
0.0
(-6.5 to 7.0)
-4.0
(-9.6 to 1.8)
-2.7
(-9.0 to 4.1)
High-density lipid cholesterol
-4.3
(-7.7 to 0.7)
-4.7
(-7.7 to -1.6)
-1.5
(-4.9 to 2.1)
Triglycerides
11.0
(2.0 to 20.9)
7.1
(-0.7 to 15.4)
6.2
(-2.4 to 15.5)
14.Secondary Outcome
Title Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12
Hide Description Urinary ACR (micrograms per milligram) was determined at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (exponent (mean change on log scale) - 1. [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]
Time Frame Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 40 51 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-27.1
(-39.9 to -11.6)
-20.1
(-32.4 to -5.5)
-21.5
(-35.2 to -4.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carvedilol CR Atenolol Lisinopril
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
Carvedilol CR Atenolol Lisinopril
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carvedilol CR Atenolol Lisinopril
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4   6   12 
Cardiac disorders       
Atrial fibrillation  1  1/91 (1.10%)  0/100 (0.00%)  2/96 (2.08%) 
Acute coronary syndrome  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Coronary artery disease  1  1/91 (1.10%)  0/100 (0.00%)  0/96 (0.00%) 
Myocardial infarction  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Eye disorders       
Vision blurred  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Gastrointestinal disorders       
Abdominal pain  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Inguinal hernia obstructive  1  0/91 (0.00%)  1/100 (1.00%)  0/96 (0.00%) 
Pancreatitis  1  0/91 (0.00%)  1/100 (1.00%)  0/96 (0.00%) 
General disorders       
Non-cardiac chest pain  1  0/91 (0.00%)  2/100 (2.00%)  1/96 (1.04%) 
Chest pain  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Immune system disorders       
Drug hypersensitivity  1  0/91 (0.00%)  1/100 (1.00%)  0/96 (0.00%) 
Metabolism and nutrition disorders       
Gout  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  0/91 (0.00%)  1/100 (1.00%)  0/96 (0.00%) 
Muscular weakness  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Nervous system disorders       
Dizziness  1  0/91 (0.00%)  0/100 (0.00%)  2/96 (2.08%) 
Transient ischemic attack  1  0/91 (0.00%)  0/100 (0.00%)  2/96 (2.08%) 
Headache  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Neuropathy peripheral  1  1/91 (1.10%)  0/100 (0.00%)  0/96 (0.00%) 
Syncope  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Psychiatric disorders       
Depression  1  1/91 (1.10%)  0/100 (0.00%)  0/96 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary mass  1  0/91 (0.00%)  0/100 (0.00%)  1/96 (1.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carvedilol CR Atenolol Lisinopril
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54   61   52 
Gastrointestinal disorders       
Diarrhea  1  5/91 (5.49%)  7/100 (7.00%)  7/96 (7.29%) 
General disorders       
Fatigue  1  6/91 (6.59%)  16/100 (16.00%)  5/96 (5.21%) 
Edema peripheral  1  6/91 (6.59%)  7/100 (7.00%)  5/96 (5.21%) 
Infections and infestations       
Nasopharyngitis  1  6/91 (6.59%)  9/100 (9.00%)  8/96 (8.33%) 
Upper respiratory tract infection  1  5/91 (5.49%)  3/100 (3.00%)  7/96 (7.29%) 
Bronchitis  1  6/91 (6.59%)  4/100 (4.00%)  2/96 (2.08%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms  1  6/91 (6.59%)  3/100 (3.00%)  4/96 (4.17%) 
Nervous system disorders       
Headache  1  13/91 (14.29%)  11/100 (11.00%)  10/96 (10.42%) 
Dizziness  1  13/91 (14.29%)  8/100 (8.00%)  6/96 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  8/91 (8.79%)  5/100 (5.00%)  16/96 (16.67%) 
Dyspnea  1  3/91 (3.30%)  7/100 (7.00%)  0/96 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00108082     History of Changes
Other Study ID Numbers: COR100216
First Submitted: April 13, 2005
First Posted: April 14, 2005
Results First Submitted: August 13, 2009
Results First Posted: November 9, 2009
Last Update Posted: December 16, 2016