Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose
NCT ID: NCT00034840
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
490 participants
INTERVENTIONAL
2001-10-31
2002-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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telmisartan, valsartan
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Are not surgically sterile.
* Are nursing.
* Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. No exceptions will be made.
2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
3. Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
4. Known or suspected secondary hypertension (i.e., pheochromocytoma).
5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range.
* Serum creatinine \> 2.3 mg/dL (or \> 203 µmol/l).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past three months prior to signing the informed consent form.
14. Stroke within the past six months prior to signing the informed consent form.
15. Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
16. PTCA (percutaneous transluminal coronary revascularization) within the past three months prior to signing the informed consent form.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
19. 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%.
20. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
21. History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
22. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
23. Any investigational therapy within one month of signing the informed consent form.
24. Known hypersensitivity to any component of the formulations.
25. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
26. Inability to comply with the protocol.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Bayer
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Memorial Research Medical Clinic
Long Beach, California, United States
National Research Institute
Los Angeles, California, United States
Orange County Research Center
Orange, California, United States
University of Conn. Health Services Center, Hypertension and Vascular Disease
Farmington, Connecticut, United States
Alan Graff
Fort Lauderdale, Florida, United States
Greater Ft. Lauderdale Heart Group Research
Fort Lauderdale, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
So. Clinical Research and Management, Inc.
Augusta, Georgia, United States
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, United States
University of Maryland/Nephrology Clinical Research Unit
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, United States
Michael A. Azorr, M.D.
Portland, Oregon, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Trinity Hypertension Research Institute/Punzi Medical Center
Carrollton, Texas, United States
UW Health/Physicians Plus Center for Clinical Trials
Madison, Wisconsin, United States
Heart Health Institute
Calgary, Alberta, Canada
Dr. Dennis O'Keefe
Mount Pearl, Newfoundland and Labrador, Canada
Dr. William Booth
Antigonish, Nova Scotia, Canada
MSHJ Research Assoc.
Halifax, Nova Scotia, Canada
Dr. Joseph Berlingieri
Burlington, Ontario, Canada
Dr. William Mahoney
Corunna, Ontario, Canada
BBM Clinical Research Ltd.
Courtice, Ontario, Canada
Dr. Richard Tytus
Hamilton, Ontario, Canada
Total Concept Health Care
Kitchener, Ontario, Canada
Centre for Activity and Aging
London, Ontario, Canada
Dr. Martyn Chilvers
Sarnia, Ontario, Canada
Sunnybrook & Women's College Health Centre
Toronto, Ontario, Canada
Theradev Clinical Research, Inc.
Granby, Quebec, Canada
Invascor, Longueuil
Longueuil, Quebec, Canada
Hotel Dieu de St-Jerome
Saint-Jérôme, Quebec, Canada
Centre de Cardiologie
Saint-Lambert, Quebec, Canada
Centre Hospital Quebec - PAC CHUL Unite de Recherche
Sainte-Foy, Quebec, Canada
Q&T Research
Sherbrooke, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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502.327
Identifier Type: -
Identifier Source: org_study_id