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

This study has been completed.
Sponsor:
Collaborators:
Great Lakes Drug Development, Inc.
Integrium
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00817414
First received: January 5, 2009
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Hypertension
 Drug: Placebo
Drug: LCI699
 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 Controlled, Multi-center Study to Evaluate the Effects of LCI699 on Cortisol in Patients With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics of LCI699 in hypertensive patients [ Time Frame: Predose, week 1, week 4 and week 6. ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of LCI699 in hypertensive patients [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817414

Locations
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
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: NCT00817414     History of Changes
Other Study ID Numbers: CLCI699A2215, EudraCT 2008-007337-49
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
Cortisol

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013