Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344110

CSPP100A1301

Details and patient eligibility

About

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Enrollment: 768 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 20 - 75 years old
• Gender: Male or female
• Status: Outpatients
• Mild to moderate essential hypertension

Exclusion criteria

• Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
• Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3
• Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
• Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind