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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00168779 |
Purpose
The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg Drug: valsartan 160 mg / hydrochlorothiazide 25 mg Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Forced-titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients Iwth Stage 1 or Stage 2 Hypertension |
| Estimated Enrollment: | 1125 |
| Study Start Date: | September 2005 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| 502.476.014 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| 502.476.031 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| 502.476.037 Boehringer Ingelheim Investigational Site | |
| Mobile, Alabama, United States | |
| 502.476.079 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| 502.476.071 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| 502.476.074 Boehringer Ingelheim Investigational Site | |
| Athens, Alabama, United States | |
| 502.476.059 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| 502.476.110 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| 502.476.061 Boehringer Ingelheim Investigational Site | |
| Glendale, Arizona, United States | |
| United States, Arkansas | |
| 502.476.066 Boehringer Ingelheim Investigational Site | |
| Carlisle, Arkansas, United States | |
| United States, California | |
| 502.476.005 Boehringer Ingelheim Investigational Site | |
| Long Beach, California, United States | |
| 502.476.029 Boehringer Ingelheim Investigational Site | |
| Redondo Beach, California, United States | |
| 502.476.026 Boehringer Ingelheim Investigational Site | |
| Spring Valley, California, United States | |
| 502.476.024 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 502.476.033 Boehringer Ingelheim Investigational Site | |
| Tulsa, California, United States | |
| 502.476.048 Boehringer Ingelheim Investigational Site | |
| Riverside, California, United States | |
| 502.476.050 Boehringer Ingelheim Investigational Site | |
| Santa Ana, California, United States | |
| 502.476.067 Boehringer Ingelheim Investigational Site | |
| Buena Park, California, United States | |
| 502.476.087 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 502.476.086 Boehringer Ingelheim Investigational Site | |
| Encinitas, California, United States | |
| 502.476.073 Boehringer Ingelheim Investigational Site | |
| Sacramento, California, United States | |
| 502.476.111 Boehringer Ingelheim Investigational Site | |
| San Fransisco, California, United States | |
| 502.476.124 Boehringer Ingelheim Investigational Site | |
| Greenbrae, California, United States | |
| United States, Colorado | |
| 502.476.019 Boehringer Ingelheim Investigational Site | |
| Boulder, Colorado, United States | |
| 502.476.101 Boehringer Ingelheim Investigational Site | |
| Highlands Ranch, Colorado, United States | |
| United States, Connecticut | |
| 502.476.053 Boehringer Ingelheim Investigational Site | |
| Farmington, Connecticut, United States | |
| United States, Delaware | |
| 502.476.032 Boehringer Ingelheim Investigational Site | |
| Newark, Delaware, United States | |
| United States, Florida | |
| 502.476.012 Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| 502.476.015 Boehringer Ingelheim Investigational Site | |
| Ft. Lauderdale, Florida, United States | |
| 502.476.021 Boehringer Ingelheim Investigational Site | |
| Panama City, Florida, United States | |
| 502.476.036 Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| 502.476.041 Boehringer Ingelheim Investigational Site | |
| Coral Gables, Florida, United States | |
| 502.476.058 FPA Clinical Research | |
| Kissimmee, Florida, United States | |
| 502.476.052 Boehringer Ingelheim Investigational Site | |
| Largo, Florida, United States | |
| 502.476.044 Boehringer Ingelheim Investigational Site | |
| Hollywood, Florida, United States | |
| 502.476.065 Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| 502.476.080 Boehringer Ingelheim Investigational Site | |
| Melbourne, Florida, United States | |
| 502.476.108 Boehringer Ingelheim Investigational Site | |
| Deland, Florida, United States | |
| United States, Georgia | |
| 502.476.008 Boehringer Ingelheim Investigational Site | |
| Conyers, Georgia, United States | |
| 502.476.075 Boehringer Ingelheim Investigational Site | |
| Decatur, Georgia, United States | |
| 502.476.049 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| 502.476.022 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| 502.476.004 Boehringer Ingelheim Investigational Site | |
| Peoria, Illinois, United States | |
| 502.476.018 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| 502.476.047 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| 502.476.051 Boehringer Ingelheim Investigational Site | |
| Indianapolis, Indiana, United States | |
| 502.476.084 Boehringer Ingelheim Investigational Site | |
| South Bend, Indiana, United States | |
| 502.476.063 Boehringer Ingelheim Investigational Site | |
| Evansville, Indiana, United States | |
| 502.476.062 Boehringer Ingelheim Investigational Site | |
| Evansville, Indiana, United States | |
| 502.476.090 Boehringer Ingelheim Investigational Site | |
| South Bend, Indiana, United States | |
| United States, Kansas | |
| 502.476.003 Boehringer Ingelheim Investigational Site | |
| Wichita, Kansas, United States | |
| 502.476.038 Boehringer Ingelheim Investigational Site | |
| Wichita, Kansas, United States | |
| 502.476.100 Boehringer Ingelheim Investigational Site | |
| Newton, Kansas, United States | |
| United States, Kentucky | |
| 502.476.002 Boehringer Ingelheim Investigational Site | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| 502.476.116 Boehringer Ingelheim Investigational Site | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| 502.476.035 Boehringer Ingelheim Investigational Site | |
| Oxon Hill, Maryland, United States | |
| United States, Michigan | |
| 502.476.010 Boehringer Ingelheim Investigational Site | |
| Troy, Michigan, United States | |
| United States, Minnesota | |
| 502.476.028 Boehringer Ingelheim Investigational Site | |
| Brooklyn Center, Minnesota, United States | |
| 502.476.057 Boehringer Ingelheim Investigational Site | |
| Edina, Minnesota, United States | |
| United States, Missouri | |
| 502.476.055 Boehringer Ingelheim Investigational Site | |
| Kansas City, Missouri, United States | |
| 502.476.114 Boehringer Ingelheim Investigational Site | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| 502.476.112 Boehringer Ingelheim Investigational Site | |
| Omaha, Nebraska, United States | |
| 502.476.126 Boehringer Ingelheim Investigational Site | |
| Omaha, Nebraska, United States | |
| United States, Nevada | |
| 502.476.125 Boehringer Ingelheim Investigational Site | |
| Las Vegas, Nevada, United States | |
| United States, New Jersey | |
| 502.476.088 Boehringer Ingelheim Investigational Site | |
| Ship Bottom, New Jersey, United States | |
| 502.476.089 Boehringer Ingelheim Investigational Site | |
| Turnersville, New Jersey, United States | |
| 502.476.120 Boehringer Ingelheim Investigational Site | |
| Berlin, New Jersey, United States | |
| United States, New York | |
| 502.476.020 Boehringer Ingelheim Investigational Site | |
| Northport, New York, United States | |
| 502.476.091 Boehringer Ingelheim Investigational Site | |
| Williamsville, New York, United States | |
| 502.476.068 Boehringer Ingelheim Investigational Site | |
| Brooklyn, New York, United States | |
| 502.476.025 Boehringer Ingelheim Investigational Site | |
| Rochester, New York, United States | |
| 502.476.122 Boehringer Ingelheim Investigational Site | |
| Hamburg, New York, United States | |
| United States, North Carolina | |
| 502.476.027 Boehringer Ingelheim Investigational Site | |
| Winston Salem, North Carolina, United States | |
| 502.476.042 Boehringer Ingelheim Investigational Site | |
| Raleigh, North Carolina, United States | |
| 502.476.046 Boehringer Ingelheim Investigational Site | |
| Burlington, North Carolina, United States | |
| 502.476.083 Boehringer Ingelheim Investigational Site | |
| Charlotte, North Carolina, United States | |
| 502.476.095 Boehringer Ingelheim Investigational Site | |
| Salisbury, North Carolina, United States | |
| United States, Ohio | |
| 502.476.016 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| 502.476.023 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| 502.476.034 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 502.476.060 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 502.476.064 Boehringer Ingelheim Investigational Site | |
| Kettering, Ohio, United States | |
| 502.476.103 Boehringer Ingelheim Investigational Site | |
| Olmstead Township, Ohio, United States | |
| 502.476.128 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| 502.476.007 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| 502.476.030 Boehringer Ingelheim Investigational Site | |
| Tulsa, Oklahoma, United States | |
| 502.476.113 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| 502.476.104 Boehringer Ingelheim Investigational Site | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| 502.476.072 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| 502.476.109 Boehringer Ingelheim Investigational Site | |
| Erie, Pennsylvania, United States | |
| 502.476.094 Boehringer Ingelheim Investigational Site | |
| Harleysville, Pennsylvania, United States | |
| 502.476.076 Boehringer Ingelheim Investigational Site | |
| Springfield, Pennsylvania, United States | |
| 502.476.121 Boehringer Ingelheim Investigational Site | |
| Penndel, Pennsylvania, United States | |
| United States, Rhode Island | |
| 502.476.013 Boehringer Ingelheim Investigational Site | |
| East Providence, Rhode Island, United States | |
| United States, Tennessee | |
| 502.476.081 Boehringer Ingelheim Investigational Site | |
| New Tazewell, Tennessee, United States | |
| 502.476.082 Boehringer Ingelheim Investigational Site | |
| Selmer, Tennessee, United States | |
| 502.476.085 Boehringer Ingelheim Investigational Site | |
| Cordova, Tennessee, United States | |
| 502.476.096 Boehringer Ingelheim Investigational Site | |
| Jackson, Tennessee, United States | |
| United States, Texas | |
| 502.476.039 Boehringer Ingelheim Investigational Site | |
| Carrolton, Texas, United States | |
| 502.476.056 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 502.476.069 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 502.476.070 Boehringer Ingelheim Investigational Site | |
| Killeen, Texas, United States | |
| 502.476.107 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| United States, Utah | |
| 502.476.017 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| 502.476.006 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| 502.476.001 Boehringer Ingelheim Investigational Site | |
| Bountiful, Utah, United States | |
| 502.476.097 Boehringer Ingelheim Investigational Site | |
| Sandy, Utah, United States | |
| 502.476.098 Boehringer Ingelheim Investigational Site | |
| Sandy, Utah, United States | |
| United States, Virginia | |
| 502.476.011 Boehringer Ingelheim Investigational Site | |
| Falls Church, Virginia, United States | |
| 502.476.093 Boehringer Ingelheim Investigational Site | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| 502.476.078 Boehringer Ingelheim Investigational Site | |
| Tacoma, Washington, United States | |
| United States, Wisconsin | |
| 502.476.105 Boehringer Ingelheim Investigational Site | |
| Milwaukee, Wisconsin, United States | |
| 502.476.106 Boehringer Ingelheim Investigational Site | |
| Menomonee Falls, Wisconsin, United States | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 502.476 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00168779 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Benzoates Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions |
Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Valsartan Hypertension |