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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double-Blind, Parallel Assignment |
| Conditions: |
Hypertension Left Ventricular Hypertrophy |
| Interventions: |
Drug: carvedilol MR Drug: atenolol Drug: lisinopril |
Baseline Characteristics
| 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. |
| 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 |
Outcome Measures
| 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ 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 [ Month 12 (If Month 12 data were not available, the LOCF was used) ] |
More Information
| 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. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | COR100216 |
| Study First Received: | April 13, 2005 |
| Results First Received: | August 13, 2009 |
| Last Updated: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00108082 History of Changes |
| Health Authority: | United States: Food and Drug Administration |