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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary

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 Summary:
Sponsor: Novartis

Current Primary Outcome: Systolic blood pressure over a 7-week forced titration treatment period [ Time Frame: 7 weeks ]

Original Primary Outcome: Systolic blood pressure over a 7-week forced titration treatment period

Current Secondary Outcome: 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 ]

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

Information By: Novartis

Dates:
Date Received: August 5, 2008
Date Started: June 2008
Date Completion:
Last Updated: August 25, 2009
Last Verified: August 2009