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
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

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

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:	63
Study Start Date:	December 2008
Primary Completion Date:	July 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

Eligibility

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
Long Beach Center for Clinical Research
Long Beach, California, United States, 90806
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Innovative Clinical Research, Inc
Harbor City, California, United States, 90710
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States, 90620
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
dgd Research, Inc
San Antonio, Texas, United States, 78229
Punzi Medical Center
Carollton, Texas, United States, 75006
Iceland, SA
Encode Clinic
Reykjavik, SA, Iceland

Sponsors and Collaborators

Novartis

Great Lakes Drug Development, Inc.

Integrium

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLCI699A2215, EudraCT 2008-007337-49
Study First Received:	January 5, 2009
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00817414 History of Changes
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:

Anti-Inflammatory Agents
Hydrocortisone
Cortisol succinate

Vascular Diseases
Hydrocortisone acetate
Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Hydrocortisone
Therapeutic Uses
Vascular Diseases

Cardiovascular Diseases
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on September 02, 2009