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This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate essential hypertension. Safety will also be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPP100 (aliskiren) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| effect of aliskiren on the RAS profile | ||
| relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren | ||
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Inclusion Criteria:
Japanese patients with mild to moderate essential hypertension aged 20 to 80 years
Blood pressure: Mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:
Body weight no less than 50 kg
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigative Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Tokyo | 160-8618 | Japan |
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| Label | URL |
|---|---|
| Results for CSPP100A1104 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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| safety |