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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

August 5, 2008
August 25, 2009
June 2008
May 2009   (final data collection date for primary outcome measure)
Systolic blood pressure over a 7-week forced titration treatment period [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Systolic blood pressure over a 7-week forced titration treatment period
Complete list of historical versions of study NCT00732771 on ClinicalTrials.gov Archive Site
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 ]
Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period
Not Provided
Not Provided
 
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
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

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Primary Hyperaldosteronism
Drug: LCI699
Experimental: LCI696 1mg bid
Intervention: Drug: LCI699

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
May 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00732771
CLCI699A2206
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Novartis investigator site
Novartis
August 2009

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