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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Coreg CR + lisinopril |
|
| 2 | Experimental | Coreg CR + placebo |
|
| 3 | Experimental | lisinopril + placebo |
|
| 4 | Placebo Comparator | placebo + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carvedilol phosphate | Drug | Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Score (DS) Among the Treatment Groups | Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble. | Baseline and nine months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay N Cohn, MD | Professor, University of Minnesota, Cardiology Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, Variety Club Research Center 102 | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Coreg CR + Lisinopril | Coreg CR + lisinopril carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
| FG001 | 2 Coreg CR + Placebo | Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months |
| FG002 | 3 Lisinopril + Placebo | lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
| FG003 | 4 Placebo + Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Coreg CR + Lisinopril | Coreg CR + lisinopril carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
| BG001 | 2 Coreg CR + Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Disease Score (DS) Among the Treatment Groups | Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble. | Calculation for change is the value at the later time point minus the value at the earlier time point. | Posted | Mean | Standard Deviation | Overall Rasmussen Disease Score Change | Baseline and nine months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Coreg CR + Lisinopril | Coreg CR + lisinopril carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stroke | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay N. Cohn, M.D. | University of Minnesota Medical School | 612.625.5646 | cohnx001@umn.edu |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| lisinopril | Drug | tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
|
| carvedilol phosphate and lisinopril | Drug | carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
|
|
| placebo and placebo | Drug | capsule once daily for 9 months; dosage unknown |
|
Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months |
| BG002 | 3 Lisinopril + Placebo | lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
| BG003 | 4 Placebo + Placebo |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 2 Coreg CR + Placebo | Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months |
| OG002 | 3 Lisinopril + Placebo | lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months |
| OG003 | 4 Placebo + Placebo |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 2 Coreg CR + Placebo | Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months | 0 | 24 | 0 | 24 |
| EG002 | 3 Lisinopril + Placebo | lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months | 1 | 22 | 0 | 22 |
| EG003 | 4 Placebo + Placebo | 0 | 24 | 0 | 24 |
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| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |