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

Phase 2

Completed

• Conditions: Primary Hyperaldosteronism
• Interventions: Drug: LCI699

• Registration Number: NCT00732771
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-12
• Primary Completion: 2009-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-25
• Last Update Posted: 2009-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCI696 1mg bid	LCI699	-

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure over a 7-week forced titration treatment period	7 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigator Site; 🇫🇷 France, France