Status:
COMPLETED
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
Lead Sponsor:
Novartis
Conditions:
Primary Hyperaldosteronism
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.
Eligibility Criteria
Inclusion
- Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA).
- Hypertension at screening
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00732771
Start Date
June 1 2008
Last Update
August 26 2009
Active Locations (1)
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1
Novartis Investigator Site
France, France