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

Primary Hyperaldosteronism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732771
• Other study ID #: CLCI699A2206
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2008
• Last updated: August 25, 2009
• Start date: June 2008

Study information

• Verified date: August 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Hyperaldosteronism

Intervention

Drug:
• LCI699

Locations

Country	Name	City	State
France	Novartis Investigator Site	France

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure over a 7-week forced titration treatment period		7 weeks	No
Secondary	Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period		7 weeks	Yes