A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
NCT ID: NCT00817635
Last Updated: 2021-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2008-12-22
2009-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LCI699 0.25 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
LCI699
LCI699 oral capsules
LCI699 1 mg QD
Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 weeks.
LCI699
LCI699 oral capsules
LCI699 0.5 mg followed by LCI699 1 mg BID
Following a 2-week placebo run-in period, participants received LCI699 0.5 mg, capsules, orally, BID, with or without food for up to 4 weeks, followed by LCI699 1 mg, capsules, orally, BID with or without food for up to 4 weeks.
LCI699
LCI699 oral capsules
Eplerenone 50 mg BID
Following a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
Eplerenone
Eplerenone oral capsules
Placebo
For a 2-week placebo run-in period, followed by 8 weeks of the treatment period, participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food.
LCI699-matching Placebo
LCI699-matching placebo oral capsules
Eplerenone-matching Placebo
Eplerenone-matching placebo oral capsules
Interventions
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LCI699
LCI699 oral capsules
Eplerenone
Eplerenone oral capsules
LCI699-matching Placebo
LCI699-matching placebo oral capsules
Eplerenone-matching Placebo
Eplerenone-matching placebo oral capsules
Eligibility Criteria
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Inclusion Criteria
* Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
* Male and female participants 18 to 75 years of age
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)
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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Horizon Research Group, Inc
Mobile, Alabama, United States
Cochise Clinical Research
Sierra Vista, Arizona, United States
Clinical Solutions Advantage
Buena Park, California, United States
Michael Waldman, MD
Irvine, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
Clinical Trials Research
Roseville, California, United States
Orange County Research Center
Tustin, California, United States
Metro Clinical Research
Littleton, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Clinical Research of So. Florida
Coral Gables, Florida, United States
Jacksonville Heart Center
Jacksonville Beach, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Accelovance
Melbourne, Florida, United States
Cardio-Pulminary Associates
Plantation, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Northwest Clinical Trials
Boise, Idaho, United States
Provident Clinical Research
Addison, Illinois, United States
Cedar-Crosse Research Centereet
Chicago, Illinois, United States
Provident Clinical Research
Bloomington, Indiana, United States
Accelovance
South Bend, Indiana, United States
Peter A. Holt
Baltimore, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Chelsea Internal Medicine
Chelsea, Michigan, United States
New York Cardiovascular Associates
New York, New York, United States
Charlotte Clinical Research
Charlotte, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, United States
Medical Research South
Charleston, South Carolina, United States
Mountain View Clinical Research Associates
Greer, South Carolina, United States
Clinical Research Associates, Inc
Nashville, Tennessee, United States
Punzi Medical Center
Carrollton, Texas, United States
KRK Medical Research
Dallas, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Daniel Gottlieb, MD
Burien, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Gemini Scientific
Madison, Wisconsin, 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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2008-007338-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCI699A2216
Identifier Type: -
Identifier Source: org_study_id
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