Trial · NCT00108082
The CLEVER Study - Coreg And Left Ventricular Mass Regression
NCT00108082, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The CLEVER Study - Coreg And Left Ventricular Mass Regression. Trials, record NCT00108082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00108082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The CLEVER Study - Coreg And Left Ventricular Mass Regression
- NCT number
- NCT00108082
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 287 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertrophy, Left Ventricular
- Interventions
- carvedilol MR, atenolol, lisinopril
- First posted
- 2005-04-14
- Last updated
- 2016-12-16
- Results first posted
- 2009-11-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12 | 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) | 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. |
| Secondary | Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12 | 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) | 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). |
| Secondary | Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12 | 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) | 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. |
| Secondary | Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12 | 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) | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 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) | All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | grams per meters squared (g/m^2) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 | 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) | All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | g/m raised to 2.7 (g/(m^2.7)) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 | 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) | All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | grams (g) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12 | 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) | All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | grams per meters squared (g/m^2) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12 | 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) | All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | g/m raised to 2.7 (g/(m^2.7)) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12 | 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) | All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | grams | MEAN |
| SECONDARY | Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12 | 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) | All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | milliliters (mL) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12 | 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) | All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | milliliters (mL) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12 | 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) | All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | milliliters (mL) | MEAN |
| SECONDARY | Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12 | 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) | All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12) | mmHg (millimeters of mercury) | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Carvedilol CR | -6.34 | Standard Error 0.850 | grams per meters squared (g/m^2) | |
| 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 | Atenolol | -6.67 | Standard Error 0.756 | grams per meters squared (g/m^2) | |
| 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 | Lisinopril | -7.94 | Standard Error 0.850 | grams per meters squared (g/m^2) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 | Carvedilol CR | -3.19 | Standard Error 0.407 | g/m raised to 2.7 (g/(m^2.7)) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 | Atenolol | -3.37 | Standard Error 0.361 | g/m raised to 2.7 (g/(m^2.7)) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 | Lisinopril | -3.98 | Standard Error 0.407 | g/m raised to 2.7 (g/(m^2.7)) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 | Carvedilol CR | -13.74 | Standard Error 1.732 | grams (g) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 | Atenolol | -14.17 | Standard Error 1.540 | grams (g) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 | Lisinopril | -17.17 | Standard Error 1.734 | grams (g) | |
| Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12 | Carvedilol CR | -20.35 | Standard Error 4.027 | grams per meters squared (g/m^2) |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carvedilol CR | 91 | |
| Overall Study | STARTED | Atenolol | 100 | |
| Overall Study | STARTED | Lisinopril | 96 | |
| Overall Study | COMPLETED | Carvedilol CR | 53 | |
| Overall Study | COMPLETED | Atenolol | 68 | |
| Overall Study | COMPLETED | Lisinopril | 53 | |
| Overall Study | NOT COMPLETED | Carvedilol CR | 38 | |
| Overall Study | NOT COMPLETED | Atenolol | 32 | |
| Overall Study | NOT COMPLETED | Lisinopril | 43 |
Source ClinicalTrials.gov
Adverse events99
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Carvedilol CR | 13 | 91 | |
| other | Headache | Nervous system disorders | Atenolol | 11 | 100 | |
| other | Headache | Nervous system disorders | Lisinopril | 10 | 96 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Carvedilol CR | 8 | 91 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Atenolol | 5 | 100 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Lisinopril | 16 | 96 | |
| other | Dizziness | Nervous system disorders | Carvedilol CR | 13 | 91 | |
| other | Dizziness | Nervous system disorders | Atenolol | 8 | 100 | |
| other | Dizziness | Nervous system disorders | Lisinopril | 6 | 96 | |
| other | Fatigue | General disorders | Carvedilol CR | 6 | 91 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carvedilol CR | ||
| Total, all-cause mortality | Atenolol | ||
| Total, all-cause mortality | Lisinopril | ||
| Total, other adverse events | Carvedilol CR | 54 | |
| Total, other adverse events | Atenolol | 61 | |
| Total, other adverse events | Lisinopril | 52 | |
| Total, serious adverse events | Carvedilol CR | 4 | |
| Total, serious adverse events | Atenolol | 6 | |
| Total, serious adverse events | Lisinopril | 12 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00108082
GET https://conductscience.org/api/trials/v1/NCT00108082/results?page=2