Hypertension
Conditions
Keywords
Hypertension, Aliskiren
Brief summary
This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.
Interventions
DRUGAliskiren
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Mild to moderate essential hypertension 2. Age: ≥20 years old and \<80 years old (at time informed consent obtained) 3. Sex: N/A 4. Admission status: Outpatient
Exclusion criteria
1. Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant 2. Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3 3. Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension 4. Patients suspected of having malignant hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting diastolic blood pressure after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure after 8 weeks | — |
| Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks | — |
| Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks | — |
Countries
Japan
Outcome results
None listed