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An Evaluation of the Effects of LCI699 on Cortisol in Patients With Hypertension

This study has been completed.
Great Lakes Drug Development, Inc.
Information provided by (Responsible Party):
Novartis Identifier:
First received: January 5, 2009
Last updated: November 30, 2012
Last verified: November 2012
This study will determine the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in patients with hypertension

Condition Intervention Phase
Drug: Placebo
Drug: LCI699
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Effects of LCI699 on Cortisol in Patients With Hypertension

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) of LCI699 with respect to effect on the ACTH-stimulated cortisol response following ACTH stimulation in hypertensive patients. [ Time Frame: 6 weeks of treatment ]

Secondary Outcome Measures:
  • To characterize the LCI699 exposure-response relationship on cortisol levels following ACTH stimulation in hypertensive patients. [ Time Frame: 6 weeks of treatment ]
  • To characterize the pharmacokinetics of LCI699 in hypertensive patients [ Time Frame: Predose, week 1, week 4 and week 6. ]
  • To assess the safety and tolerability of LCI699 in hypertensive patients [ Time Frame: 8 weeks ]
  • To explore the proportion of patients achieving a successful BP response and BP control in all treatment groups for 23-26 hour post dose (11-14 hour post dose for BID regimen) MSSBP and MSDBP [ Time Frame: 6 weeks after treatment ]

Enrollment: 63
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cohort A, Placebo Drug: Placebo
Experimental: Cohort A, LCI699 dosing regimen 1 Drug: LCI699
Experimental: Cohort A, LCI699 dosing regimen 2 Drug: LCI699
Placebo Comparator: Cohort B, Placebo Drug: Placebo
Experimental: Cohort B, LCI699 dosing regimen 3 Drug: LCI699
Experimental: Cohort B, LCI699 dosing regimen 4 Drug: LCI699


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of hypertension with blood pressure ≥ 140/90 mmHg and < 180/110 mmHg on current antihypertensive treatment
  • Male and female patients 18-75 years of age
  • Subjects must weigh at least 50 kg

Exclusion Criteria:

  • Recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebral 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)
  • Liver disease Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
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Please refer to this study by its identifier: NCT00817414

United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States, 90620
Innovative Clinical Research, Inc
Harbor City, California, United States, 90710
Long Beach Center for Clinical Research
Long Beach, California, United States, 90806
United States, Colorado
Metro Clinical Research
Littleton, Colorado, United States, 80120
United States, North Carolina
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States, 28801
Northstate Clinical Research
Lenior, North Carolina, United States, 28645
United States, Pennsylvania
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, United States, 16684
United States, Texas
Punzi Medical Center
Carollton, Texas, United States, 75006
dgd Research, Inc
San Antonio, Texas, United States, 78229
Encode Clinic
Reykjavik, SA, Iceland
Sponsors and Collaborators
Great Lakes Drug Development, Inc.
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00817414     History of Changes
Other Study ID Numbers: CLCI699A2215
EudraCT 2008-007337-49
Study First Received: January 5, 2009
Last Updated: November 30, 2012

Keywords provided by Novartis:
Blood Pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents processed this record on April 26, 2017