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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: LCI699-matching Placebo; Drug: Eplerenone-matching Placebo; Drug: LCI699; Drug: Eplerenone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00817635

2008-007338-23 (EudraCT Number)

CLCI699A2216

Details and patient eligibility

About

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

Enrollment: 155 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 5 patient groups, including a placebo group

LCI699 0.25 mg BID

Experimental group

Description:

Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.

Treatment:

Drug: LCI699

LCI699 1 mg QD

Experimental group

Description:

Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.

Treatment:

Drug: LCI699

LCI699 0.5 mg followed by LCI699 1 mg BID

Experimental group

Description:

Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.

Treatment:

Drug: LCI699

Eplerenone 50 mg BID

Active Comparator group

Description:

Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.

Treatment:

Drug: Eplerenone

Placebo

Placebo Comparator group

Description:

For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.

Treatment:

Drug: Eplerenone-matching Placebo

Drug: LCI699-matching Placebo