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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732771
First Posted: August 12, 2008
Last Update Posted: August 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
August 5, 2008
August 12, 2008
August 26, 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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00732771
CLCI699A2206
Not Provided
Not Provided
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