A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Finding Study to Evaluate the Efficacy and Safety of LCI699, a New Experimental Antihypertensive Drug, in Patients With Essential Hypertension
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This study is a proof-of-efficacy, dose finding study of LCI699 in patients with mild-to-moderate uncomplicated essential hypertension in order to assess the BP lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Finding Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Males and non-fertile females
18-75 years inclusive
Patients with mild-to-moderate uncomplicated essential hypertension
All women of child bearing potential.
Female patients on hormone replacement therapy.
History or evidence of a secondary form of hypertension
Known moderate or malignant retinopathy
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (NYHA class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for patients participating in the study
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the trial period.
Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment
Treatment with potassium supplement or potassium sparing diuretics
Treatment with potent CYP3A4 inhibitors during the study period
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 mEq/L or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
ALT or AST > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
MDRD eGFR < 60 ml/min/1.73 m2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol)