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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: LCI699-matching placebo; Drug: LCI699

Study type: Interventional

Funder types: Industry

Identifiers

NCT00817414

CLCI699A2215

2008-007337-49 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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63 participants in 5 patient groups, including a placebo group

Cohort A: LCI699 0.5 mg QD

Experimental group

Description:

Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.

Treatment:

Drug: LCI699

Cohort A: LCI699 1.0 mg QD

Experimental group

Description:

Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.

Treatment:

Drug: LCI699

Cohort B1: LCI699 1.0 mg BID

Experimental group

Description:

Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.

Treatment:

Drug: LCI699

Cohort B1: LCI699 2.0 mg QD

Experimental group

Description:

Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.

Treatment:

Drug: LCI699

Placebo

Placebo Comparator group

Description:

Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks.

Treatment:

Drug: LCI699-matching placebo