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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00860262 |
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff SBP compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
Condition | Intervention | Phase |
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Hypertension |
Drug: telmisartan Drug: amlodipine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8-Week Randomised, Double-Blind Study to Compare the Fixed-Dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3). |
Estimated Enrollment: | 760 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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 signing informed consent) who:
The only acceptable methods of birth control are:
Intra Uterine Device (IUD) Oral Implantable or injectable contraceptives Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
Renal dysfunction as defined by the following laboratory parameters:
Serum creatinine >3.0 mg/dL (or >265 mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1235.20, 2008-000873-40 |
Study First Received: | March 11, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00860262 History of Changes |
Health Authority: | Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; France: AFFSAPS; Hungary: National Institute of Pharmacy, H-1051 Budapest; Korea, Republic of: Korea Food and Drug Administration (KFDA); Romania: National Medicines Agency, Bucharest; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Agencia Española del medicamento y Productos Sanitarios (AEMPS) Subdirección General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAIN; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Vasodilator Agents Vascular Diseases Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Angiotensin II Amlodipine |
Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Calcium, Dietary Angiotensin-Converting Enzyme Inhibitors Telmisartan Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Amlodipine Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |