Expired Study
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East Hanover, New Jersey


Purpose:

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.


Criteria:

Inclusion Criteria: - Males and non-fertile females - 18-75 years inclusive - Patients with mild-to-moderate uncomplicated essential hypertension Exclusion Criteria: - All women of child bearing potential. - Female patients on hormone replacement therapy. - Severe hypertension - 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) - Patients with night-shift employment.


NCT ID:

NCT00758524


Primary Contact:

Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals


Backup Contact:

N/A


Location Contact:

East Hanover, New Jersey
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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