Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension
Launched by BOEHRINGER INGELHEIM · Sep 12, 2005
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Ability to provide written informed consent.
- • 2. Age 18 years or older
- • 3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
- • 4. Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)
- Exclusion Criteria:
- 1. Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:
- • 1. are not surgically sterile and/or
- • 2. are nursing or pregnant
- • 3. are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of \> 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
- • 2. Known or suspected secondary hypertension.
- • 3. Mean seated SBP \>= 180 mmHg or mean seated DBP \>= 120 mmHg during any clinic visit prior to randomization.
- 4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- • 1. SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range, or
- • 2. Serum creatinine \> 3.0 mg/dL or creatinine clearance \< 0.6 ml/sec.
- • 5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
- • 6. Clinically relevant hypokalemia or hyperkalemia.
- • 7. Uncorrected volume depletion.
- • 8. Uncorrected sodium depletion.
- • 9. Primary aldosteronism.
- • 10. Hereditary fructose intolerance.
- • 11. Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
- • 12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
- • 13. History of drug or alcohol dependency within six months prior to start of run-in period.
- • 14. Chronic administration of any medications known to affect blood pressure, exc
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Athens, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Glendale, Arizona, United States
Carlisle, Arkansas, United States
Buena Park, California, United States
Encinitas, California, United States
Greenbrae, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Redondo Beach, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Spring Valley, California, United States
Tulsa, California, United States
Boulder, Colorado, United States
Highlands Ranch, Colorado, United States
Farmington, Connecticut, United States
Newark, Delaware, United States
Coral Gables, Florida, United States
Deland, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Kissimmee, Florida, United States
Largo, Florida, United States
Melbourne, Florida, United States
Panama City, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Conyers, Georgia, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Evansville, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
South Bend, Indiana, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Oxon Hill, Maryland, United States
Troy, Michigan, United States
Brooklyn Center, Minnesota, United States
Edina, Minnesota, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Ship Bottom, New Jersey, United States
Turnersville, New Jersey, United States
Brooklyn, New York, United States
Hamburg, New York, United States
Northport, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
Burlington, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Olmstead Township, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Penndel, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Springfield, Pennsylvania, United States
East Providence, Rhode Island, United States
Cordova, Tennessee, United States
Jackson, Tennessee, United States
New Tazewell, Tennessee, United States
Selmer, Tennessee, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Killeen, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Sandy, Utah, United States
Sandy, Utah, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Tacoma, Washington, United States
Menomonee Falls, Wisconsin, United States
Milwaukee, Wisconsin, United States
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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