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

Novartis12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Hyperaldosteronism

Interventions

LCI699DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigator Site

France, France

Outcomes

Primary Outcomes

Systolic blood pressure over a 7-week forced titration treatment period

Time frame: 7 weeks

Secondary Outcomes

Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period

Time frame: 7 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.