A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension
NCT ID: NCT00817414
Last Updated: 2021-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2009-01-14
2009-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort A: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.
LCI699
LCI699 oral capsules
Cohort A: LCI699 1.0 mg QD
Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
LCI699
LCI699 oral capsules
Cohort B1: LCI699 1.0 mg BID
Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
LCI699
LCI699 oral capsules
Cohort B1: LCI699 2.0 mg QD
Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.
LCI699
LCI699 oral capsules
Placebo
Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks.
LCI699-matching placebo
LCI699-matching placebo oral capsules
Interventions
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LCI699-matching placebo
LCI699-matching placebo oral capsules
LCI699
LCI699 oral capsules
Eligibility Criteria
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Inclusion Criteria
* Male and female participants 18-75 years of age
* Participants must weigh at least 50 kilograms (kg)
Exclusion Criteria
* Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
* Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c \[HbA1c\] \> 9%)
* Malignancies within the last 5 years (excluding basal cell skin cancer)
* Liver disease
18 Years
75 Years
ALL
No
Sponsors
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Great Lakes Drug Development, Inc.
INDUSTRY
Integrium
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Impact Clinical Trials
Beverly Hills, California, United States
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States
Innovative Clinical Research, Inc
Harbor City, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
Metro Clinical Research
Littleton, Colorado, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, United States
Punzi Medical Center
Carrollton, Texas, United States
dgd Research, Inc
San Antonio, Texas, United States
Encode Clinic
Reykjavik, SA, Iceland
Countries
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References
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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.
Other Identifiers
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2008-007337-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCI699A2215
Identifier Type: -
Identifier Source: org_study_id
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