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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00699192 |
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Amlodipine/Valsartan Drug: Amlodipine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily |
Estimated Enrollment: | 670 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Amlodipine/Valsartan 5/80 mg: Experimental | Drug: Amlodipine/Valsartan |
Amlodipine/Valsartan 5/40 mg: Active Comparator | Drug: Amlodipine/Valsartan |
Amlodipine 5 mg: Active Comparator | Drug: Amlodipine |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply" at the end of this section
Contact: Novartis Pharmaceuticals | 41.61.324.1111 |
Czech Republic | |
Novartis Investigative site | Recruiting |
Brno, Czech Republic | |
Contact: Novartis Pharmaceuticals 41.61.324.1111 | |
Investigative sites Czech Republic | Recruiting |
Praha, Czech Republic | |
Contact: Novartis Pharmaceuticals 41.61.324.1111 | |
Investigative sites Czech Repbulic | Recruiting |
Hodonin, Czech Republic | |
Contact: Novartis Pharmaceuticals 41.61.324.1111 | |
Sites in Czech Republic | Recruiting |
Nachod, Czech Republic | |
Contact: novartis pharma 41.61.324.1111 | |
Investigative site Czech Republic | Recruiting |
Chrudim, Czech Republic | |
Contact: Novartis pharma 41.61.324.1111 | |
Investigative site Czech Repbulic | Recruiting |
Jicin, Czech Republic | |
Contact: novartis Pharma 41.61.324.1111 | |
Finland | |
Investigative site Finland | Recruiting |
Joensuu, Finland | |
Contact: Novartis pharma 41.61.324.1111 | |
Investigative site Finland | Recruiting |
Tampere, Finland | |
Contact: Novartis Pharma 41.61.324.1111 | |
Investigative site Finland | Recruiting |
Kerava, Finland | |
Contact: Novartis Pharma | |
Investigative site Finland | Recruiting |
Helsinki, Finland | |
Contact: Novartis Pharma 41.61.324.1111 | |
France | |
Investigative site France | Not yet recruiting |
Paris, France | |
Germany | |
Investigative site Germany | Not yet recruiting |
Berlin, Germany | |
Contact: Novartis Pharma 41.61.324.1111 | |
Hungary | |
Investigative site Hungary | Recruiting |
Budapest, Hungary | |
Contact: Novartis Pharma 41.61.324.1111 | |
Italy | |
Investigative site Italy | Recruiting |
Rome, Italy | |
Contact: Novartis Pharma 41.61.324.1111 | |
Poland | |
Investigative site Poland | Not yet recruiting |
Warsaw, Poland | |
Contact: Novartis pharma 41.61.324.1111 | |
Slovakia | |
Investigative site Slovakia | Recruiting |
Bratislava, Slovakia | |
Contact: Novartis Pharma 41.61.324.1111 | |
Spain | |
Investigative site Spain | Recruiting |
Valencia, Spain | |
Contact: Novartis pharma 41.61.324.1111 | |
Sweden | |
Investigative site Sweden | Not yet recruiting |
Malmo, Sweden | |
Contact: Novartis pharma 41.61.324.1111 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CVAA489A2318 |
Study First Received: | June 9, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00699192 |
Health Authority: | Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM); Hungary: Országos Gyógyszerészeti Intézet; Italy: Ministry of Health; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Poland: THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS |
Blood pressure hypertension elderly |
Calcium, Dietary Vascular Diseases Essential hypertension |
Valsartan Amlodipine Hypertension |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |