An Evaluation of the Effects of LCI699 on Cortisol in Patients With Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Placebo (Drug); LCI699 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
Summary
This study will determine the maximum dose of LCI6999 with respect to effect on the
ACTH-stimulated cortisol response in patients with hypertension
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: 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.
Secondary outcome: To characterize the LCI699 exposure-response relationship on cortisol levels following ACTH stimulation in hypertensive patients.To characterize the pharmacokinetics of LCI699 in hypertensive patients To assess the safety and tolerability of LCI699 in hypertensive patients 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, Phone: 862-778-8300
Long Beach Center for Clinical Research, Long Beach, California 90806, United States; Recruiting
Brittany Weichers, Phone: 562-595-9366, Email: b.weichers@lbccr.com
Impact Clinical Trials, Beverly Hills, California 90211, United States; Recruiting
Lindsey Nigro, Phone: 310-289-8242, Email: lnigro@impactla.org
Innovative Clinical Research, Inc, Harbor City, California 90710, United States; Recruiting
Sheena Cecille Marie Tan Go, Phone: 310-534-4883, Email: innovative.clinical.trials@gmail.com
Associated Pharmaceutical Research Center, Inc, Buena Park, California 90620, United States; Recruiting
Marivic Dario, Phone: 714-952-2233, Email: research@associatedpharma.com
Metro Clinical Research, Littleton, Colorado 80120, United States; Recruiting
Denise Mack, Phone: 303-880-3411, Email: MetroClinicalResearch@yahoo.com
Clinical Study Center of Asheville, LLC, Asheville, North Carolina 28801, United States; Recruiting
Roberta Naimark, Phone: 828-253-5600, Email: RNaimark131csca@bellsouth.net
Northstate Clinical Research, Lenior, North Carolina 28645, United States; Recruiting
Janie Probst, Phone: 828-728-1125, Email: northstate@charterinternet.com
Tipton Medical & Diagnostic Center, Tipton, Pennsylvania 16684, United States; Recruiting
Shari Edevane, Phone: 814-684-4600, Ext: 2314, Email: research_nurse77@yahoo.com
Encode Clinic, Reykjavik, SA, Iceland; Recruiting
J Johanna Fridbjorg Sigurjonsdottir, Phone: +354 510 9900, Email: johanna@encode.is
dgd Research, Inc, San Antonio, Texas 78229, United States; Recruiting
Donna Baldwin, Phone: 210-615-5506, Email: donna.baldwin@dgdresearch.com
Punzi Medical Center, Carollton, Texas 75006, United States; Recruiting
Kathy Cassidy, Phone: 972-478-7700, Email: clinicalresearch@punzimedicalcenter.com
Additional Information
Starting date: December 2008
Last updated: January 5, 2009
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