SPP100 Dose Finding Study in Japan

Phase 2CompletedNCT00311012

Novartis445 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

445

Conditions

Hypertension

Interventions

AliskirenDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

Tokyo, Japan

Outcomes

Primary Outcomes

Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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