Back to resultsProof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
Primary Purpose
Primary Hyperaldosteronism
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
LCI699
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hyperaldosteronism focused on measuring primary hyperaldosteronism, hypokalemia, hypertension, aldosterone synthase inhibitor
Eligibility 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
Sites / Locations
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LCI696 1mg bid
Arm Description
Outcomes
Primary Outcome Measures
Systolic blood pressure over a 7-week forced titration treatment period
Secondary Outcome Measures
Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00732771
Brief Title
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperaldosteronism
Keywords
primary hyperaldosteronism, hypokalemia, hypertension, aldosterone synthase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LCI696 1mg bid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LCI699
Primary Outcome Measure Information:
Title
Systolic blood pressure over a 7-week forced titration treatment period
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis investigator site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
France
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24107737
Citation
Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.
Results Reference
derived
PubMed Identifier
20837883
Citation
Amar L, Azizi M, Menard J, Peyrard S, Watson C, Plouin PF. Aldosterone synthase inhibition with LCI699: a proof-of-concept study in patients with primary aldosteronism. Hypertension. 2010 Nov;56(5):831-8. doi: 10.1161/HYPERTENSIONAHA.110.157271. Epub 2010 Sep 13.
Results Reference
derived
Learn more about this trial
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism
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