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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Bayer | INDUSTRY |
The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan, valsartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose | after 6 to 8 weeks | |
| Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication | after 6 to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose | after 6 to 8 weeks | |
| Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment | after 6 to 8 weeks |
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Inclusion Criteria:
1. Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP of greater than or equal to 85 mm Hg.
Exclusion Criteria:
Pre-menopausal women (last menstruation = 1 year prior to signing informed consent) who:
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
Known or suspected secondary hypertension (i.e., pheochromocytoma).
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
Uncorrected volume depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Biliary obstructive disorders.
Congestive heart failure (NYHA functional class CHF III-IV).
Unstable angina within the past three months prior to signing the informed consent form.
Stroke within the past six months prior to signing the informed consent form.
Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
PTCA (percutaneous transluminal coronary revascularization) within the past three months prior to signing the informed consent form.
Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C =10%.
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
Any investigational therapy within one month of signing the informed consent form.
Known hypersensitivity to any component of the formulations.
Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
Inability to comply with the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Research Medical Clinic | Long Beach | California | 90806 | United States | ||
| National Research Institute |
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| Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose | 8 weeks |
| Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose | 8 weeks |
| Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose | 8 weeks |
| Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose | 8 weeks |
| Responder rates based on ABPM | after 6 to 8 weeks |
| Responder rates based on in-clinic trough cuff blood pressures | after 6 to 8 weeks |
| Los Angeles |
| California |
| 90057 |
| United States |
| Orange County Research Center | Orange | California | 92868 | United States |
| University of Conn. Health Services Center, Hypertension and Vascular Disease | Farmington | Connecticut | 06030 | United States |
| Alan Graff | Fort Lauderdale | Florida | 33308 | United States |
| Greater Ft. Lauderdale Heart Group Research | Fort Lauderdale | Florida | 33308 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32806 | United States |
| So. Clinical Research and Management, Inc. | Augusta | Georgia | 30904 | United States |
| Rush Presbyterian/St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| University of Maryland/Nephrology Clinical Research Unit | Baltimore | Maryland | 21201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Oklahoma Cardiovascular and Hypertension Center | Oklahoma City | Oklahoma | 73132 | United States |
| Michael A. Azorr, M.D. | Portland | Oregon | 97232 | United States |
| Harleysville Medical Associates | Harleysville | Pennsylvania | 19438 | United States |
| Trinity Hypertension Research Institute/Punzi Medical Center | Carrollton | Texas | 75006 | United States |
| UW Health/Physicians Plus Center for Clinical Trials | Madison | Wisconsin | 53715 | United States |
| Heart Health Institute | Calgary | Alberta | T2E 7C5 | Canada |
| Dr. Dennis O'Keefe | Mount Pearl | Newfoundland and Labrador | A1N 2C3 | Canada |
| Dr. William Booth | Antigonish Nova Scotia | Nova Scotia | B2G 2C2 | Canada |
| MSHJ Research Assoc. | Halifax | Nova Scotia | B3K 5R3 | Canada |
| Dr. Joseph Berlingieri | Burlington | Ontario | L7R 2H3 | Canada |
| Dr. William Mahoney | Corunna | Ontario | N0N 1G0 | Canada |
| BBM Clinical Research Ltd. | Courtice | Ontario | L1E 3C3 | Canada |
| Dr. Richard Tytus | Hamilton | Ontario | L8M 1K7 | Canada |
| Total Concept Health Care | Kitchener | Ontario | N2C 2N9 | Canada |
| Centre for Activity and Aging | London | Ontario | N6G 2M3 | Canada |
| Dr. Martyn Chilvers | Sarnia | Ontario | N7T 4X3 | Canada |
| Sunnybrook & Women's College Health Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Theradev Clinical Research, Inc. | Granby | Quebec | J2G 8Z9 | Canada |
| Invascor, Longueuil | Longueuil | Quebec | J4N 1E1 | Canada |
| Hotel Dieu de St-Jerome | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Centre de Cardiologie | Saint-Lambert | Quebec | J4P 2H4 | Canada |
| Centre Hospital Quebec - PAC CHUL Unite de Recherche | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Q&T Research | Sherbrooke | Quebec | J1H 4J6 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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