|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 5 mg Drug: Valsartan 80 mg Drug: Valsartan 40 mg Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 965 |
| Study Start Date: | May 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Amlodipine/Valsartan 5/80 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Drug: Amlodipine 5 mg
1 capsule amlodipine 5 mg orally once daily
Drug: Valsartan 80 mg
1 capsule valsartan 80 mg orally once daily
|
|
Active Comparator: Amlodipine/Valsartan 5/40 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Drug: Amlodipine 5 mg
1 capsule amlodipine 5 mg orally once daily
Drug: Valsartan 40 mg
1 capsule valsartan 40 mg orally once daily
|
|
Active Comparator: Amlodipine 5 mg
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
Drug: Amlodipine 5 mg
1 capsule amlodipine 5 mg orally once daily
Drug: Placebo
1 capsule placebo to match valsartan orally once daily
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Diagnosed as having hypertension:
Exclusion criteria
Contacts and Locations| Czech Republic | |
| Novartis Investigative site | |
| Brno, Czech Republic | |
| Investigative site Czech Republic | |
| Chrudim, Czech Republic | |
| Investigative sites Czech Repbulic | |
| Hodonin, Czech Republic | |
| Investigative site Czech Repbulic | |
| Jicin, Czech Republic | |
| Sites in Czech Republic | |
| Nachod, Czech Republic | |
| Investigative sites Czech Republic | |
| Praha, Czech Republic | |
| Finland | |
| Investigative site Finland | |
| Helsinki, Finland | |
| Investigative site Finland | |
| Joensuu, Finland | |
| Investigative site Finland | |
| Kerava, Finland | |
| Investigative site Finland | |
| Tampere, 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: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00699192 History of Changes |
| Other Study ID Numbers: | CVAA489A2318 |
| Study First Received: | June 9, 2008 |
| Results First Received: | January 11, 2011 |
| Last Updated: | May 4, 2011 |
| 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: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
|
Blood pressure hypertension elderly |
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Amlodipine, valsartan drug combination Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |