SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Novartis40 enrolled

Overview

Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction

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 * Elevated Serum Creatinine Exclusion Criteria: * Patients suspected of malignant hypertension * Patients with a clinically significant allergy * Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

Japan, Japan

Outcomes

Primary Outcomes

Adverse events after 8 weeks

Secondary Outcomes

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

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

Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks

Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks

Blood pressure <140/90 after 8 weeks

Data from ClinicalTrials.gov

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