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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00732771
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperaldosteronism	Drug: LCI699	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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 Hyperaldosteronism
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LCI696 1mg bid	Drug: LCI699

Outcome Measures

Primary Outcome Measures

1. Systolic blood pressure over a 7-week forced titration treatment period [7 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigator Site	France		France

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Novartis, Novartis investigator site

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00732771
• Other Study ID Numbers: CLCI699A2206
• First Posted: Aug 12, 2008
• Last Update Posted: Aug 26, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: primary hyperaldosteronism; hypokalemia; hypertension; aldosterone synthase inhibitor
• Additional relevant MeSH terms: Hyperaldosteronism

Study Results

No Results Posted as of Aug 26, 2009