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

Condition Intervention Phase
Primary Hyperaldosteronism Drug: LCI699 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Systolic blood pressure over a 7-week forced titration treatment period [ Time Frame: 7 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: June 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCI696 1mg bid Drug: LCI699

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732771


Locations
France
Novartis Investigator Site
France, France
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00732771     History of Changes
Other Study ID Numbers: CLCI699A2206
First Submitted: August 5, 2008
First Posted: August 12, 2008
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Novartis:
primary hyperaldosteronism
hypokalemia
hypertension
aldosterone synthase inhibitor

Additional relevant MeSH terms:
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases