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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00699192 |
Purpose
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 |
| Study Completion Date: | June 2009 |
| 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 |
Eligibility| 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
Contacts and Locations| Czech Republic | |
| Novartis Investigative site | |
| Brno, Czech Republic | |
| Investigative sites Czech Republic | |
| Praha, Czech Republic | |
| Investigative sites Czech Repbulic | |
| Hodonin, Czech Republic | |
| Sites in Czech Republic | |
| Nachod, Czech Republic | |
| Investigative site Czech Republic | |
| Chrudim, Czech Republic | |
| Investigative site Czech Repbulic | |
| Jicin, Czech Republic | |
| Finland | |
| Investigative site Finland | |
| Joensuu, Finland | |
| Investigative site Finland | |
| Tampere, Finland | |
| Investigative site Finland | |
| Kerava, Finland | |
| Investigative site Finland | |
| Helsinki, Finland | |
| France | |
| Investigative site France | |
| Paris, France | |
| Germany | |
| Investigative site Germany | |
| Berlin, Germany | |
| Hungary | |
| Investigative site Hungary | |
| Budapest, Hungary | |
| Italy | |
| Investigative site Italy | |
| Rome, Italy | |
| Poland | |
| Investigative site Poland | |
| Warsaw, Poland | |
| Slovakia | |
| Investigative site Slovakia | |
| Bratislava, Slovakia | |
| Spain | |
| Investigative site Spain | |
| Valencia, Spain | |
| Sweden | |
| Investigative site Sweden | |
| Malmo, Sweden | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CVAA489A2318 |
| Study First Received: | June 9, 2008 |
| Last Updated: | February 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00699192 History of Changes |
| Health Authority: | Czech Republic: State Institute for Drug Control; Finland: Finnish Medicines Agency; 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 |
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Blood pressure hypertension elderly |
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Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Amlodipine Membrane Transport Modulators Therapeutic Uses Cardiovascular Diseases Valsartan Hypertension |