A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension

• Status: Completed
• Trial end date: 2009-08-12
• Target enrollment: 0
• Participant gender: All

Summary

This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.

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

Details

• Lead Sponsor: Novartis
• Collaborators: Great Lakes Drug Development, Inc.; Integrium
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg) and < 180/110 mmHg on current antihypertensive treatment

• Male and female participants 18-75 years of age

• Participants must weigh at least 50 kilograms (kg)

Exclusion Criteria:

• Recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebral 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)

• Liver disease

Other protocol-defined inclusion/exclusion criteria may apply.