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The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ali/Amlo | Experimental | Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ali/Amlo 150/2.5 mg | Drug | Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of the fixed-dose combination of aliskiren/ amlodipine | Measure the number patients withof AE, SAEs and analyze cahanges in safety labs. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine. | this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Yokohama | Kanagawa | 231-0023 | Japan | ||
| Novartis Investigative Site |
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| The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study | 52 weeks |
| Koshigaya |
| Saitama |
| 343-0826 |
| Japan |
| Novartis Investigative Site | Edogawa-ku | Tokyo | 133-0061 | Japan |
| Novartis Investigative Site | Katsushika-ku | Tokyo | 124-0024 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-0021 | Japan |
| Novartis Investigative Site | Kunitachi | Tokyo | 186-0001 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-7390 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 108-0075 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 143-0023 | Japan |
| Novartis Investigative Site | Shibuya-ku | Tokyo | 150-0002 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141-0032 | Japan |
| Novartis Investigative Site | Tachikawa | Tokyo | 190-0013 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0021 | Japan |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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