A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
A Phase II, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Multi-center, Dose Ranging Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo After 8 Weeks Treatment in Patients With Resistant Hypertension
2 other identifiers
interventional
155
2 countries
38
Brief Summary
This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hypertension
Started Dec 2008
Shorter than P25 for phase_2 hypertension
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2009
CompletedResults Posted
Study results publicly available
June 2, 2021
CompletedJune 2, 2021
May 1, 2021
10 months
January 5, 2009
May 6, 2021
May 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF)
Arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and country as factors and Baseline MSSBP as a covariate.
Baseline, Week 8
Secondary Outcomes (15)
Change From Baseline in MSDBP at Week 8 LOCF
Baseline, Week 8
Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8, as Measured by Office Blood Pressure (OBP)
Week 8
Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8, as Measured by OBP
Week 8
Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSSBP at Week 8
Baseline, Week 8
Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSDBP at Week 8
Baseline, Week 8
- +10 more secondary outcomes
Study Arms (5)
LCI699 0.25 mg BID
EXPERIMENTALFollowing 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 1 mg QD
EXPERIMENTALFollowing 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 0.5 mg followed by LCI699 1 mg BID
EXPERIMENTALFollowing 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.
Eplerenone 50 mg BID
ACTIVE COMPARATORFollowing a 2-week placebo run-in period, participants received eplerenone 50 mg, capsules, orally, BID, with or without food for up to 8 weeks.
Placebo
PLACEBO COMPARATORFor 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.
Interventions
LCI699 oral capsules
Eligibility Criteria
You may qualify if:
- Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and \<180 mmHg
- 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
You may not qualify if:
- Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Great Lakes Drug Development, Inc.collaborator
- Integriumcollaborator
Study Sites (38)
Horizon Research Group, Inc
Mobile, Alabama, 36608, United States
Cochise Clinical Research
Sierra Vista, Arizona, 85635, United States
Clinical Solutions Advantage
Buena Park, California, 90620, United States
Michael Waldman, MD
Irvine, California, 92618, United States
Long Beach Center for Clinical Research
Long Beach, California, 90806, United States
Clinical Trials Research
Roseville, California, 95661, United States
Orange County Research Center
Tustin, California, 92780, United States
Metro Clinical Research
Littleton, Colorado, 80120, United States
Meridien Research
Bradenton, Florida, 34203, United States
Clinical Research of So. Florida
Coral Gables, Florida, 33134, United States
Jacksonville Heart Center
Jacksonville Beach, Florida, 32250, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Accelovance
Melbourne, Florida, 32935, United States
Cardio-Pulminary Associates
Plantation, Florida, 33317, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Provident Clinical Research
Addison, Illinois, 60101, United States
Cedar-Crosse Research Centereet
Chicago, Illinois, 60607, United States
Provident Clinical Research
Bloomington, Indiana, 47403, United States
Accelovance
South Bend, Indiana, 46601, United States
Peter A. Holt
Baltimore, Maryland, 21239, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Chelsea Internal Medicine
Chelsea, Michigan, 48118, United States
New York Cardiovascular Associates
New York, New York, 10001, United States
Charlotte Clinical Research
Charlotte, North Carolina, 28211, United States
Northstate Clinical Research
Lenoir, North Carolina, 28645, United States
Community Research
Cincinnati, Ohio, 45245, United States
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, 16684, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Mountain View Clinical Research Associates
Greer, South Carolina, 29651, United States
Clinical Research Associates, Inc
Nashville, Tennessee, 37203, United States
Punzi Medical Center
Carrollton, Texas, 75006, United States
KRK Medical Research
Dallas, Texas, 75230, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Daniel Gottlieb, MD
Burien, Washington, 98166, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Gemini Scientific
Madison, Wisconsin, 83719, United States
Encode Clinic
Reykjavik, SA, Iceland
Related Publications (1)
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.
PMID: 24107737DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
December 22, 2008
Primary Completion
October 13, 2009
Study Completion
October 13, 2009
Last Updated
June 2, 2021
Results First Posted
June 2, 2021
Record last verified: 2021-05