A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.

Key facts

Study ID

NCT00817635

Run by

Novartis

People needed

155

Starts

2008-12-22

Expected to finish

2009-10-13

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and <180 mmHg
• Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
• Male and female participants 18 to 75 years of age

You may not qualify if…

• Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular 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)
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Horizon Research Group, Inc — Mobile, Alabama, United States
• Cochise Clinical Research — Sierra Vista, Arizona, United States
• Clinical Solutions Advantage — Buena Park, California, United States
• Michael Waldman, MD — Irvine, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Clinical Trials Research — Roseville, California, United States
• Orange County Research Center — Tustin, California, United States
• Metro Clinical Research — Littleton, Colorado, United States
• Meridien Research — Bradenton, Florida, United States
• Clinical Research of So. Florida — Coral Gables, Florida, United States
• Jacksonville Heart Center — Jacksonville Beach, Florida, United States
• FPA Clinical Research — Kissimmee, Florida, United States
• Accelovance — Melbourne, Florida, United States
• Cardio-Pulminary Associates — Plantation, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Provident Clinical Research — Addison, Illinois, United States
• Cedar-Crosse Research Centereet — Chicago, Illinois, United States
• Provident Clinical Research — Bloomington, Indiana, United States
• Accelovance — South Bend, Indiana, United States
• Peter A. Holt — Baltimore, Maryland, United States
• MD Medical Research — Oxon Hill, Maryland, United States
• Chelsea Internal Medicine — Chelsea, Michigan, United States
• New York Cardiovascular Associates — New York, New York, United States
• Charlotte Clinical Research — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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