Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

Novartis

Status and phase: Completed; Phase 2

Conditions: Primary Hyperaldosteronism

Treatments: Drug: LCI699

Study type: Interventional

Funder types: Industry

Identifiers

NCT00732771

CLCI699A2206

Details and patient eligibility

About

The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA).
• Hypertension at screening

Exclusion criteria

• Persistent hypokalemia
• Renal impairment
• Significant hepatic disease
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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12 participants in 1 patient group

LCI696 1mg bid

Experimental group

Treatment:

Drug: LCI699