Status:
COMPLETED
A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension
Lead Sponsor:
Novartis
Collaborating Sponsors:
Great Lakes Drug Development, Inc.
Integrium
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.
Eligibility Criteria
Inclusion
- Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg) and \< 180/110 mmHg on current antihypertensive treatment
- Male and female participants 18-75 years of age
- Participants must weigh at least 50 kilograms (kg)
Exclusion
- 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 electrocardiography (ECG) findings related to cardiac conduction defects
- Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c \[HbA1c\] \> 9%)
- Malignancies within the last 5 years (excluding basal cell skin cancer)
- Liver disease
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 14 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00817414
Start Date
January 14 2009
End Date
August 12 2009
Last Update
June 2 2021
Active Locations (11)
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1
Impact Clinical Trials
Beverly Hills, California, United States, 90211
2
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States, 90620
3
Innovative Clinical Research, Inc
Harbor City, California, United States, 90710
4
Long Beach Center for Clinical Research
Long Beach, California, United States, 90806