An Evaluation of the Effects of LCI699 on Cortisol in Patients With Hypertension - Full Text View

Sponsors and Collaborators:	Novartis Great Lakes Drug Development, Inc. Integrium, LLC
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00817414

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 II

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

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 ]

Estimated Enrollment:	90
Study Start Date:	December 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort A, Placebo: Placebo Comparator	Drug: Placebo
Cohort A, LCI699 dosing regimen 1: Experimental	Drug: LCI699
Cohort A, LCI699 dosing regimen 2: Experimental	Drug: LCI699
Cohort B, Placebo: Placebo Comparator	Drug: Placebo
Cohort B, LCI699 dosing regimen 3: Experimental	Drug: LCI699
Cohort B, LCI699 dosing regimen 4: Experimental	Drug: LCI699
Cohort C, Placebo: Placebo Comparator	Drug: Placebo
Cohort C, LCI699 dosing regimen 5: Experimental	Drug: LCI699
Cohort C, LCI699 dosing regimen 6: Experimental	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

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, California
Long Beach Center for Clinical Research	Recruiting
Long Beach, California, United States, 90806
Contact: Brittany Weichers 562-595-9366 b.weichers@lbccr.com
Impact Clinical Trials	Recruiting
Beverly Hills, California, United States, 90211
Contact: Lindsey Nigro 310-289-8242 lnigro@impactla.org
Innovative Clinical Research, Inc	Recruiting
Harbor City, California, United States, 90710
Contact: Sheena Cecille Marie Tan Go 310-534-4883 innovative.clinical.trials@gmail.com
Associated Pharmaceutical Research Center, Inc	Recruiting
Buena Park, California, United States, 90620
Contact: Marivic Dario 714-952-2233 research@associatedpharma.com
United States, Colorado
Metro Clinical Research	Recruiting
Littleton, Colorado, United States, 80120
Contact: Denise Mack 303-880-3411 MetroClinicalResearch@yahoo.com
United States, North Carolina
Clinical Study Center of Asheville, LLC	Recruiting
Asheville, North Carolina, United States, 28801
Contact: Roberta Naimark 828-253-5600 RNaimark131csca@bellsouth.net
Northstate Clinical Research	Recruiting
Lenior, North Carolina, United States, 28645
Contact: Janie Probst 828-728-1125 northstate@charterinternet.com
United States, Pennsylvania
Tipton Medical & Diagnostic Center	Recruiting
Tipton, Pennsylvania, United States, 16684
Contact: Shari Edevane 814-684-4600 ext 2314 research_nurse77@yahoo.com
United States, Texas
dgd Research, Inc	Recruiting
San Antonio, Texas, United States, 78229
Contact: Donna Baldwin 210-615-5506 donna.baldwin@dgdresearch.com
Punzi Medical Center	Recruiting
Carollton, Texas, United States, 75006
Contact: Kathy Cassidy 972-478-7700 clinicalresearch@punzimedicalcenter.com
Iceland, SA
Encode Clinic	Recruiting
Reykjavik, SA, Iceland
Contact: J Johanna Fridbjorg Sigurjonsdottir +354 510 9900 johanna@encode.is

Sponsors and Collaborators

Novartis

Great Lakes Drug Development, Inc.

Integrium, LLC

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLCI699A2215, EudraCT 2008-007337-49
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00817414
Health Authority:	United States: Food and Drug Administration; Iceland: Icelandic Medicines Control Agency

Keywords provided by Novartis:

Blood Pressure
Hypertension
Cortisol

Study placed in the following topic categories:

Hydrocortisone
Cortisol succinate
Vascular Diseases
Hydrocortisone acetate
Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009