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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00732771

First received: August 5, 2008

Last updated: August 25, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2008

Last Updated Date

August 25, 2009

Start Date ^ICMJE

June 2008

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Systolic blood pressure over a 7-week forced titration treatment period [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00732771 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Hyperaldosteronism

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Primary Hyperaldosteronism

Intervention ^ICMJE

Drug: LCI699

Study Arm (s)

Experimental: LCI696 1mg bid

Intervention: Drug: LCI699

Publications *

Amar L, Azizi M, Menard J, Peyrard S, Watson C, Plouin PF. Aldosterone synthase inhibition with LCI699: a proof-of-concept study in patients with primary aldosteronism. Hypertension. 2010 Nov;56(5):831-8. Epub 2010 Sep 13.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00732771

Other Study ID Numbers ^ICMJE

CLCI699A2206

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Novartis

Novartis investigator site

Information Provided By

Novartis

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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