Heart Failure, Congestive and Microalbuminuria Clinical Trial
Official title:
A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria
| Verified date | January 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1220 |
| Est. completion date | May 2006 |
| Est. primary completion date | May 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion criteria: - Documented history of hypertension. - Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks. - Persistent microalbuminuria. Exclusion criteria: - History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease. - Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | GSK Investigational Site | Bay Roberts | Newfoundland and Labrador |
| Canada | GSK Investigational Site | Bonaventure | Quebec |
| Canada | GSK Investigational Site | Brampton | Ontario |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Charlottetown | Prince Edward Island |
| Canada | GSK Investigational Site | Hamilton | Ontario |
| Canada | GSK Investigational Site | Kitchener | Ontario |
| Canada | GSK Investigational Site | London | Ontario |
| Canada | GSK Investigational Site | Mirabel | Quebec |
| Canada | GSK Investigational Site | Montague | Prince Edward Island |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | New Westminster | British Columbia |
| Canada | GSK Investigational Site | Pointe-Claire | Quebec |
| Canada | GSK Investigational Site | Saint-Romuald | Quebec |
| Canada | GSK Investigational Site | Stoney Creek | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Trois Rivieres | Quebec |
| Canada | GSK Investigational Site | Vancouver | British Columbia |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Puerto Rico | GSK Investigational Site | Rio Grande | |
| Puerto Rico | GSK Investigational Site | San Juan | |
| United States | GSK Investigational Site | Avon | Indiana |
| United States | GSK Investigational Site | Ayer | Massachusetts |
| United States | GSK Investigational Site | Beaumont | Texas |
| United States | GSK Investigational Site | Beaver | Pennsylvania |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Buffalo | New York |
| United States | GSK Investigational Site | Burke | Virginia |
| United States | GSK Investigational Site | Camillus | New York |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | East Providence | Rhode Island |
| United States | GSK Investigational Site | East Syracuse | New York |
| United States | GSK Investigational Site | Edmonds | Washington |
| United States | GSK Investigational Site | Elkhart | Indiana |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Fullerton | California |
| United States | GSK Investigational Site | Galveston | Texas |
| United States | GSK Investigational Site | Greensboro | North Carolina |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Havertown | Pennsylvania |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Inglewood | California |
| United States | GSK Investigational Site | Johnson City | Tennessee |
| United States | GSK Investigational Site | Kettering | Ohio |
| United States | GSK Investigational Site | Kingston | New York |
| United States | GSK Investigational Site | Lafayette | Louisiana |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Melrose Park | Illinois |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Midland | Texas |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Oakland | California |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Olympia | Washington |
| United States | GSK Investigational Site | Orangeburg | South Carolina |
| United States | GSK Investigational Site | Oregon City | Oregon |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Port Chester | New York |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Reading | Pennsylvania |
| United States | GSK Investigational Site | Redondo Beach | California |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Springfield | Virginia |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Voorhees | New Jersey |
| United States | GSK Investigational Site | Wenatchee | Washington |
| United States | GSK Investigational Site | West Grove | Pennsylvania |
| United States | GSK Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. | Baseline (Randomization Visit) and Month 6 | ||
| Secondary | Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy. | Month 6 | ||
| Secondary | Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy. | Month 6 | ||
| Secondary | Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP) | Baseline (Randomization Visit) and Month 6 | ||
| Secondary | Change from Pre-screening visit to month 6 LOCF in urine ACR. | Pre-screening Visit and Month 6 | ||
| Secondary | 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 | ||
| Secondary | Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment. | Baseline (Randomization Visit) and Month 6 | ||
| Secondary | Changes from baseline in heart rate at month 6 of treatment. | Baseline (Randomization visit) and Month 6 | ||
| Secondary | Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study. | Up to 6 months | ||
| Secondary | Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment. | Up to 6 months | ||
| Secondary | Number of participants with vital signs of potential clinical concern at any time on-treatment. | Up to 6 months |