SPP100 Dose Finding Study in Japan

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311012

CSPP100A1201

Details and patient eligibility

About

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.

Enrollment: 445 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind