SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Phase 3CompletedNCT00299806

Novartis39 enrolled

Overview

Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

AliskirenDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 20 - 80 years old * Gender: Male or female * Status: Outpatients * severe hypertension Exclusion Criteria: * Patients with a clinically significant allergy * Patients who have received other investigational drug * Alcoholic patients Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

Japan, Japan

Outcomes

Primary Outcomes

Incidence of adverse events after 8 weeks

Secondary Outcomes

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

Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks

Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.

Data from ClinicalTrials.gov

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