A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension

• Status: Completed
• Trial end date: 2009-10-13
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Collaborators: Great Lakes Drug Development, Inc.; Integrium
• Treatments: Eplerenone

Criteria

Inclusion criteria:

• Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and <180 mmHg

• Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension

• Male and female participants 18 to 75 years of age

Exclusion criteria:

• Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack

• Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects

• Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c [HbA1c] >9%)

• Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply.