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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00614380 |
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A5 or T80/A5 during long-term open-label treatment.
Condition | Intervention | Phase |
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Hypertension |
Drug: telmisartan/amlodipine 40/5 mg fixed combination Drug: telmisartan/amlodipine 80/5 mg fixed combination |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension. |
Estimated Enrollment: | 974 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | March 2009 (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:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1235.7, EUDRACT2007-002410-19 |
Study First Received: | January 28, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00614380 |
Health Authority: | Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada (TPD); Denmark: Lægemiddelstyrelsen, Kliniske forsøg, Inspektionen Axel Heides Gade 1, DK-2300 Copenhagen S; Finland: National Agency for Medicines; France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE; Korea, Republic of: Korea Food and Drug Administration (KFDA); Netherlands: Central Committee on Research involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Philippines: Department of Health, Republic of the Philippines; South Africa: Medicines Control Council; Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency; Taiwan: Department of Health, Executive Yuan, Taiwan; United States: Food and Drug Administration |
Calcium, Dietary Vascular Diseases Telmisartan |
Angiotensin II Amlodipine Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Angiotensin II Type 1 Receptor Blockers Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |