Hypertension Clinical Trial
Official title:
A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) With Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients
| Verified date | March 2018 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.
| Status | Completed |
| Enrollment | 514 |
| Est. completion date | December 28, 2007 |
| Est. primary completion date | December 1, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Documented history of hypertension - Triglycerides of 120-400 mg/mL - LDLc levels not requiring lipid lowering medication. Exclusion Criteria: - Has known contraindication to alpha- or beta-blocker therapy. - Has taken any non-ocular beta-blockers within three months before screening. - Has Type I or II diabetes. - Taking lipid lowering medications. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | GSK Investigational Site | Brampton | Ontario |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Gatineau | Quebec |
| Canada | GSK Investigational Site | London | Ontario |
| Canada | GSK Investigational Site | Mirabel | Quebec |
| Canada | GSK Investigational Site | Newmarket | Ontario |
| Canada | GSK Investigational Site | Peterborough | Ontario |
| Canada | GSK Investigational Site | Sarnia | Ontario |
| Canada | GSK Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | GSK Investigational Site | Sudbury | Ontario |
| Canada | GSK Investigational Site | Sudbury | Ontario |
| Canada | GSK Investigational Site | Trois Rivieres | Quebec |
| Canada | GSK Investigational Site | Truro | Nova Scotia |
| Puerto Rico | GSK Investigational Site | Ponce | |
| Puerto Rico | GSK Investigational Site | Rio Grande | |
| Puerto Rico | GSK Investigational Site | Rio Piedras | |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Altamonte Springs | Florida |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Auburn | Maine |
| United States | GSK Investigational Site | Aurora | Illinois |
| United States | GSK Investigational Site | Avon | Connecticut |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Bossier City | Louisiana |
| United States | GSK Investigational Site | Brick | New Jersey |
| United States | GSK Investigational Site | Bristol | Tennessee |
| United States | GSK Investigational Site | Brooklyn Center | Minnesota |
| United States | GSK Investigational Site | Burke | Virginia |
| United States | GSK Investigational Site | Carmichael | California |
| United States | GSK Investigational Site | Chandler | Arizona |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Corpus Christi | Texas |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | East Syracuse | New York |
| United States | GSK Investigational Site | Elizabeth | New Jersey |
| United States | GSK Investigational Site | Endwell | New York |
| United States | GSK Investigational Site | Erie | Pennsylvania |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Fayetteville | Arkansas |
| United States | GSK Investigational Site | Fishkill | New York |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Galax | Virginia |
| United States | GSK Investigational Site | Gillespie | Illinois |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Hartsville | South Carolina |
| United States | GSK Investigational Site | Healdsburg | California |
| United States | GSK Investigational Site | Henderson | Nevada |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Irvine | California |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Kettering | Ohio |
| United States | GSK Investigational Site | Kingsport | Tennessee |
| United States | GSK Investigational Site | La Jolla | California |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Lewisburg | West Virginia |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Manassas | Virginia |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | Montgomery | Alabama |
| United States | GSK Investigational Site | Natick | Massachusetts |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newport News | Virginia |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Olive Branch | Mississippi |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Poway | California |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Roswell | Georgia |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Saint Louis | Missouri |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Simpsonville | South Carolina |
| United States | GSK Investigational Site | Spring Valley | California |
| United States | GSK Investigational Site | Springfield | Missouri |
| United States | GSK Investigational Site | Springfield | Virginia |
| United States | GSK Investigational Site | Statesville | North Carolina |
| United States | GSK Investigational Site | Stockton | California |
| United States | GSK Investigational Site | Taunton | Massachusetts |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Vernon Hills | Illinois |
| United States | GSK Investigational Site | Virginia Beach | Virginia |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Walla Walla | Washington |
| United States | GSK Investigational Site | Warminster | Pennsylvania |
| United States | GSK Investigational Site | West Chester | Pennsylvania |
| United States | GSK Investigational Site | West Yarmouth | Massachusetts |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Wilmington | North Carolina |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 | Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Primary | Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6 | Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6 | Blood draw for hs-CRP. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6 | Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6 | Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6 | Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute) | Baseline and Month 6 | |
| Secondary | Change From Baseline in Weight by Treatment Group at Maintenance Month | Manual physical examination. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6 | Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6 | Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value. | Baseline and Month 6 | |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6 | Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value. | Baseline and Month 6 |
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