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Sponsored by: |
Novartis |
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 and valsartan Drug: amlodipine 5 mg |
Phase III |
MedlinePlus related topics: | High Blood Pressure |
ChemIDplus related topics: | Valsartan Amlodipine Amlodipine besylate |
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 |
1: Active Comparator |
Drug: amlodipine and valsartan
amlodipine + valsartan 5/80, once daily at 8am for 8 weeks
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2: Active Comparator |
Drug: amlodipine and valsartan
amlodipine + valsartan 5/40 mg once daily at 8am for four or 8 weeks
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3: Active Comparator |
Drug: amlodipine 5 mg
amlodipine 5 mg once daily for 8 weeks
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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 |
Novartis |
Principal Investigator: | Novartis Pharmaceuticals | Sponsor GmbH |
Responsible Party: | pharmaceuticals ( Novartis ) |
Study ID Numbers: | CVAA489A2318 |
First Received: | June 9, 2008 |
Last Updated: | June 17, 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 |
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