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Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug | |||
| Ramipril | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the last 6-hr mean DBP & SBP as measured by ABPM at the end of and 8-wk treatment period (T80 vs R5 mg) and 14-wk treatment period (T80 vs R10 mg) | Up to week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in last 6-hr ABPM mean for: pulse pressure; DBP, SBP and PP; DBP/SBP/PP in the morning, daytime and nighttime periods of the 24-hr dosing interval; Change from baseline in mean, seated, trough DBP & SBP measured by manual cuff | Up to week 14 |
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Inclusion criteria:
Exclusion criteria:
Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
Night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m.
Mean seated SBP ≥180 mmHg or mean seated DBP ≥110 mmHg during any visit of the placebo run-in period.
Known or suspected secondary hypertension (e.g., phaeochromocytoma).
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) or Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) >2 times the upper limit of normal range, or
Serum creatinine >2.3 mg/dL (or >203 μmol/l).
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.
Further exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| Boehringer Ingelheim Investigational Site |
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| Phoenix |
| Arizona |
| United States |
| Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States |
| Harold B. Betton, M.D. | Little Rock | Arkansas | United States |
| Attn: Ginger Paselk | Long Beach | California | United States |
| Boehringer Ingelheim Investigational Site | Los Angeles | California | United States |
| Boehringer Ingelheim Investigational Site | Orange | California | United States |
| Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| Boehringer Ingelheim Investigational Site | Santa Ana | California | United States |
| Boehringer Ingelheim Investigational Site | Santa Rosa | California | United States |
| Boehringer Ingelheim Investigational Site | Vista | California | United States |
| Boehringer Ingelheim Investigational Site | Hamden | Connecticut | United States |
| Boehringer Ingelheim Investigational Site | Daytona Beach | Florida | United States |
| Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States |
| Boehringer Ingelheim Investigational Site | Melbourne | Florida | United States |
| Boehringer Ingelheim Investigational Site | Marietta | Georgia | United States |
| Boehringer Ingelheim Investigational Site | Boise | Idaho | United States |
| Boehringer Ingelheim Investigational Site | Meridian | Idaho | United States |
| Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| Boehringer Ingelheim Investigational Site | Orland Park | Illinois | United States |
| GFI Pharmaceuticals | Evansville | Indiana | United States |
| Boehringer Ingelheim Investigational Site | Newton | Kansas | United States |
| Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States |
| Boehringer Ingelheim Investigational Site | Metairie | Louisiana | United States |
| Boehringer Ingelheim Investigational Site | Auburn | Maine | United States |
| Boehringer Ingelheim Investigational Site | Moorestown | New Jersey | United States |
| Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States |
| Boehringer Ingelheim Investigational Site | East Syracuse | New York | United States |
| Boehringer Ingelheim Investigational Site | White Plains | New York | United States |
| Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States |
| Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States |
| Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States |
| Boehringer Ingelheim Investigational Site | Portland | Oregon | United States |
| Boehringer Ingelheim Investigational Site | Levittown | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Anderson | South Carolina | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | United States |
| Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | United States |
| Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States |
| Boehringer Ingelheim Investigational Site | Lacey | Washington | United States |
| Boehringer Ingelheim Investigational Site | Lakewood | Washington | United States |
| Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States |
| Boehringer Ingelheim Investigational Site | Charleston | West Virginia | United States |
| Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| Boehringer Ingelheim Investigational Site | Red Deer | Alberta | Canada |
| Boehringer Ingelheim Investigational Site | Conquitlam | British Columbia | Canada |
| Boehringer Ingelheim Investigational Site | Riverview | New Brunswick | Canada |
| Boehringer Ingelheim Investigational Site | Saint John | New Brunswick | Canada |
| Boehringer Ingelheim Investigational Site | Bay Roberts | Newfoundland and Labrador | Canada |
| Boehringer Ingelheim Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada |
| Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada |
| Boehringer Ingelheim Investigational Site | Exeter | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Hastings | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Kitchener | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | North York | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Oakville | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Orléans | Ontario | Canada |
| 205-13085 Yonge St | Richmond Hill | Ontario | Canada |
| 155 Ontario Street | St. Catharines | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Thunder Bay | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Weston | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Windsor | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Winnipeg | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Charlottetown | Prince Edward Island | Canada |
| 4 rue Robinson Nord | Granby | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Longueuil | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Pointe-Claire | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Saint-Léonard | Quebec | Canada |
| 725 6E Rue | Val-d'Or | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Regina | Saskatchewan | Canada |
| Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017257 | Ramipril |
| 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 |
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