SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00299832

CSPP100A1303

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)