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This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoprolol xl | Drug | |||
| carvedilol MR | Drug | |||
| lisinopril | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. | Baseline (Randomization Visit) and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy. | Month 6 | |
| Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy. | Month 6 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35213 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| COR103560 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2017 | |
| Reset | Apr 28, 2017 | |
| Release | May 1, 2017 |
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| Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP) | Baseline (Randomization Visit) and Month 6 |
| Change from Pre-screening visit to month 6 LOCF in urine ACR. | Pre-screening Visit and Month 6 |
| Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG) | Baseline (Randomization visit) and Month 6 |
| Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment. | Baseline (Randomization Visit) and Month 6 |
| Changes from baseline in heart rate at month 6 of treatment. | Baseline (Randomization visit) and Month 6 |
| Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study. | Up to 6 months |
| Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment. | Up to 6 months |
| Number of participants with vital signs of potential clinical concern at any time on-treatment. | Up to 6 months |
| Mobile |
| Alabama |
| 36617 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85023 | United States |
| GSK Investigational Site | Fullerton | California | 92835 | United States |
| GSK Investigational Site | Inglewood | California | 90301 | United States |
| GSK Investigational Site | Los Angeles | California | 90057 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Oakland | California | 94609 | United States |
| GSK Investigational Site | Redondo Beach | California | 90277 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80919 | United States |
| GSK Investigational Site | Hollywood | Florida | 33023 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Miami | Florida | 33169 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | Sarasota | Florida | 34239 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | Decatur | Georgia | 30035 | United States |
| GSK Investigational Site | Chicago | Illinois | 60607 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Melrose Park | Illinois | 60160 | United States |
| GSK Investigational Site | Avon | Indiana | 46123 | United States |
| GSK Investigational Site | Elkhart | Indiana | 46515 | United States |
| GSK Investigational Site | Evansville | Indiana | 47713 | United States |
| GSK Investigational Site | Evansville | Indiana | 47714 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46250 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46254 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | United States |
| GSK Investigational Site | Ayer | Massachusetts | 01432 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01608 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Voorhees Township | New Jersey | 08043 | United States |
| GSK Investigational Site | Buffalo | New York | 14222 | United States |
| GSK Investigational Site | Camillus | New York | 13031 | United States |
| GSK Investigational Site | East Syracuse | New York | 13057 | United States |
| GSK Investigational Site | Kingston | New York | 12401 | United States |
| GSK Investigational Site | Port Chester | New York | 10573 | United States |
| GSK Investigational Site | Rochester | New York | 14618 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28211 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27401 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44130 | United States |
| GSK Investigational Site | Columbus | Ohio | 43210-1296 | United States |
| GSK Investigational Site | Kettering | Ohio | 45429 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Oregon City | Oregon | 97045 | United States |
| GSK Investigational Site | Beaver | Pennsylvania | 15009 | United States |
| GSK Investigational Site | Havertown | Pennsylvania | 19083 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19152 | United States |
| GSK Investigational Site | Reading | Pennsylvania | 19601 | United States |
| GSK Investigational Site | West Grove | Pennsylvania | 19390 | United States |
| GSK Investigational Site | East Providence | Rhode Island | 02914 | United States |
| GSK Investigational Site | Greer | South Carolina | 29651 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Johnson City | Tennessee | 37604 | United States |
| GSK Investigational Site | Beaumont | Texas | 77701 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Dallas | Texas | 75390-9068 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Galveston | Texas | 77555-0188 | United States |
| GSK Investigational Site | Houston | Texas | 77024 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Midland | Texas | 79705 | United States |
| GSK Investigational Site | San Antonio | Texas | 78216 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Burke | Virginia | 22015 | United States |
| GSK Investigational Site | Springfield | Virginia | 22151 | United States |
| GSK Investigational Site | Edmonds | Washington | 98026 | United States |
| GSK Investigational Site | Olympia | Washington | 98502 | United States |
| GSK Investigational Site | Spokane | Washington | 99206 | United States |
| GSK Investigational Site | Spokane | Washington | 99207 | United States |
| GSK Investigational Site | Spokane | Washington | 99208 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
| GSK Investigational Site | Calgary | Alberta | T2E 7C5 | Canada |
| GSK Investigational Site | New Westminster | British Columbia | V3L 3W4 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V7N 4M2 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3E 3P4 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3K 0Y8 | Canada |
| GSK Investigational Site | Bay Roberts | Newfoundland and Labrador | A0G 1G0 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3J1 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8L 5G8 | Canada |
| GSK Investigational Site | Kitchener | Ontario | N2G 1N9 | Canada |
| GSK Investigational Site | London | Ontario | N5W 6A2 | Canada |
| GSK Investigational Site | Stoney Creek | Ontario | L8G 2V6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Charlottetown | Prince Edward Island | C1A 5Y9 | Canada |
| GSK Investigational Site | Montague | Prince Edward Island | C0A 1R0 | Canada |
| GSK Investigational Site | Bonaventure | Quebec | G0C 1E0 | Canada |
| GSK Investigational Site | Mirabel | Quebec | J7J 2K8 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2K 4L5 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| GSK Investigational Site | Rio Grande | Puerto Rico | 00745 | Puerto Rico |
| GSK Investigational Site | San Juan | Puerto Rico | 00907 | Puerto Rico |
For additional information about this study please refer to the GSK Clinical Study Register |
| COR103560 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR103560 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR103560 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR103560 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR103560 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COR103560 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Reset | Aug 4, 2017 |
| Release | Sep 8, 2017 |
| Unrelease | Yes |
| Release | Mar 19, 2018 |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2017 | Apr 28, 2017 | |||
| May 1, 2017 | Aug 4, 2017 | |||
| Sep 8, 2017 | Yes | |||
| Mar 19, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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