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A Study to Evaluate the Effects of LCI699 on Safety and Efficacy in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic

This study has been completed.
Sponsor:
Collaborators:
Great Lakes Drug Development, Inc.
Integrium
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00817635
First received: January 5, 2009
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will assess the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in patients with resistant hypertension.


Condition Intervention Phase
Hypertension
 Drug: LCI699
Drug: Placebo
Drug: Eplerenone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in mean sitting systolic blood pressure (MSSBP) as measured by office blood pressure (OBP) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean sitting diastolic blood pressure (MSDBP) at 8 weeks as measured by OBP [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a successful BP response and BP control (MSSBP and MSDBP), as measured by OBP [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Dose/exposure BP response relationship of LCI699, as measured by OBP [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Changes from baseline in mean 24 hours, mean daytime and mean nighttime SBP and DBP, as measured by ABPM [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • To evaluate safety and tolerability of LCI699 [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: LCI699 dosing regimen 1 Drug: LCI699
Experimental: LCI699 dosing regimen 2 Drug: LCI699
Experimental: LCI699 dosing regimen 3 Drug: LCI699
Active Comparator: Eplerenone 50 mg BID Drug: Eplerenone

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Diagnosis of hypertension with MSSBP ≥ 140 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 patients 18 to 75 years of age

Exclusion criteria:

  • Recent history of MI, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
  • Clinically significant ECG findings related to cardiac conduction defects
  • Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c > 9%)
  • Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817635

  Hide Study Locations
Locations
United States, Alabama
Horizon Research Group, Inc
Mobile, Alabama, United States, 36608
United States, Arizona
Cochise Clinical Research
Sierra Vista, Arizona, United States, 85635
United States, California
Clinical Solutions Advantage
Buena Park, California, United States, 90620
Michael Waldman, MD
Irvine, California, United States, 92618
Long Beach Center for Clinical Research
Long Beach, California, United States, 90806
Clinical Trials Research
Roseville, California, United States, 95661
Orange County Research Center
Tustin, California, United States, 92780
United States, Colorado
Metro Clinical Research
Littleton, Colorado, United States, 80120
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34203
Clinical Research of So. Florida
Coral Gables, Florida, United States, 33134
Jacksonville Heart Center
Jacksonville Beach, Florida, United States, 32250
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Accelovance
Melbourne, Florida, United States, 32935
Cardio-Pulminary Associates
Plantation, Florida, United States, 33317
Meridien Research
St. Petersburg, Florida, United States, 33709
United States, Idaho
Northwest Clinical Trials
Boise, Idaho, United States, 83704
United States, Illinois
Provident Clinical Research
Addison, Illinois, United States, 60101
Cedar-Crosse Research Centereet
Chicago, Illinois, United States, 60607
United States, Indiana
Provident Clinical Research
Bloomington, Indiana, United States, 47403
Accelovance
South Bend, Indiana, United States, 46601
United States, Maryland
Peter A. Holt
Baltimore, Maryland, United States, 21239
MD Medical Research
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Chelsea Internal Medicine
Chelsea, Michigan, United States, 48118
United States, New York
New York Cardiovascular Associates
New York, New York, United States, 10001
United States, North Carolina
Charlotte Clinical Research
Charlotte, North Carolina, United States, 28211
Northstate Clinical Research
Lenior, North Carolina, United States, 28645
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45245
United States, Pennsylvania
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Medical Research South
Charleston, South Carolina, United States, 29407
Mountain View Clinical Research Associates
Greer, South Carolina, United States, 29651
United States, Tennessee
Clinical Research Associates, Inc
Nashville, Tennessee, United States, 37203
United States, Texas
Punzi Medical Center
Carrollton, Texas, United States, 75006
KRK Medical Research
Dallas, Texas, United States, 75230
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Washington
Daniel Gottlieb, MD
Burien, Washington, United States, 98166
Rainier Clinical Research Center
Renton, Washington, United States, 98057
United States, Wisconsin
Gemini Scientific
Madison, Wisconsin, United States, 83719
Iceland
Encode Clinic
Reykjavik, SA, Iceland
Sponsors and Collaborators
Novartis
Great Lakes Drug Development, Inc.
Integrium
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00817635     History of Changes
Other Study ID Numbers: CLCI699A2216, EudraCT 2008-007338-23
Study First Received: January 5, 2009
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration
Iceland: Icelandic Medicines Control Agency

Keywords provided by Novartis:
Blood Pressure
Hypertension
Resistant Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Eplerenone
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013