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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00624065 |
Purpose
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage 1 or 2 Essential Hypertension |
Drug: lisinopril + placebo Drug: carvedilol controlled release/lisinopril |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | COR111096, A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study Comparing the Proportion of Subjects With Stage 1 or 2 Essential Hypertension Who Achieve Target Blood Pressure While Receiving Either Carvedilol CR + Lisinopril or Lisinopril Monotherapy |
| Enrollment: | 348 |
| Study Start Date: | March 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| carvedilol CR + lisinopril: Experimental |
Drug: carvedilol controlled release/lisinopril
carvedilol CR + lisinopril given as separate pills
|
| lisinopril + placebo: Active Comparator |
Drug: lisinopril + placebo
lisinopril plus placebo to match carvedilol CR
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| GSK Investigational Site | |
| Mobile, Alabama, United States, 36617 | |
| United States, Arizona | |
| GSK Investigational Site | |
| Goodyear, Arizona, United States, 85395 | |
| GSK Investigational Site | |
| Litchifield Park/Arizona, Arizona, United States, 85340 | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85032 | |
| GSK Investigational Site | |
| Chandler, Arizona, United States, 77030 | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85745 | |
| GSK Investigational Site | |
| Glendale, Arizona, United States, 85308 | |
| United States, California | |
| GSK Investigational Site | |
| Poway, California, United States, 92064 | |
| GSK Investigational Site | |
| Anaheim, California, United States, 92801 | |
| GSK Investigational Site | |
| San Ramon, California, United States, 94583 | |
| GSK Investigational Site | |
| Beuna Park, California, United States, 90620 | |
| GSK Investigational Site | |
| Tustin, California, United States, 92780 | |
| GSK Investigational Site | |
| Vista, California, United States, 92081 | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| United States, Florida | |
| GSK Investigational Site | |
| West Palm Beach, Florida, United States, 33409 | |
| GSK Investigational Site | |
| Pembroke Pines, Florida, United States, 33024 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| GSK Investigational Site | |
| Tamarac, Florida, United States, 33321 | |
| GSK Investigational Site | |
| Coral Gables, Florida, United States, 33134 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33156 | |
| GSK Investigational Site | |
| Deland, Florida, United States, 32720 | |
| GSK Investigational Site | |
| Hollywood, Florida, United States, 33023 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Savannah, Georgia, United States, 31406 | |
| United States, Idaho | |
| GSK Investigational Site | |
| Nampa, Idaho, United States, 83686 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Aurora, Illinois, United States, 60504 | |
| GSK Investigational Site | |
| Gillespie, Illinois, United States, 62033 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60607 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| GSK Investigational Site | |
| Elkhart, Indiana, United States, 46514 | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46250 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67205 | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Slidell, Louisiana, United States, 70458 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Columbia, Maryland, United States, 21045 | |
| United States, Montana | |
| GSK Investigational Site | |
| Butte, Montana, United States, 59701 | |
| United States, Nebraska | |
| GSK Investigational Site | |
| Omaha, Nebraska, United States, 68134 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89119 | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89016 | |
| United States, New Mexico | |
| GSK Investigational Site | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14209 | |
| GSK Investigational Site | |
| East Syracuse, New York, United States, 13057 | |
| GSK Investigational Site | |
| Westfield, New York, United States, 14787 | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14215 | |
| GSK Investigational Site | |
| New York, New York, United States, 10075 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, North Dakota | |
| GSK Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Corvallis, Oregon, United States, 97330 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19154 | |
| GSK Investigational Site | |
| Altoona, Pennsylvania, United States, 16602 | |
| GSK Investigational Site | |
| Lansdale, Pennsylvania, United States, 19446 | |
| GSK Investigational Site | |
| Jersey Shore, Pennsylvania, United States, 17740 | |
| GSK Investigational Site | |
| Havertown, Pennsylvania, United States, 19083 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Manning, South Carolina, United States, 29102 | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29204 | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| GSK Investigational Site | |
| Sugar Land, Texas, United States, 77479 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77081 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78224 | |
| GSK Investigational Site | |
| Grand Prairie, Texas, United States, 75052 | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78705 | |
| GSK Investigational Site | |
| Georgetown, Texas, United States, 78626 | |
| United States, Utah | |
| GSK Investigational Site | |
| Draper, Utah, United States, 84020 | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84121 | |
| GSK Investigational Site | |
| Magna, Utah, United States, 84044 | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84109 | |
| GSK Investigational Site | |
| Sandy, Utah, United States, 84094 | |
| United States, Washington | |
| GSK Investigational Site | |
| Olympia, Washington, United States, 98502-8151 | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| GSK Investigational Site | |
| Gig Harbor, Washington, United States, 98335 | |
| GSK Investigational Site | |
| Bellingham/Washington, Washington, United States, 98226 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Beloit, Wisconsin, United States, 53511 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | COR111096 |
| Study First Received: | February 14, 2008 |
| Results First Received: | June 11, 2009 |
| Last Updated: | September 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00624065 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
hypertension COREG CR lisinopril target blood pressure carvedilol CR |
|
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Lisinopril Physiological Effects of Drugs Vascular Diseases Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Protective Agents Pharmacologic Actions Protease Inhibitors Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Hypertension Carvedilol |
