A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Essential Hypertension

In brief

This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.

Key facts

Study ID

NCT00758524

Run by

Novartis Pharmaceuticals

People needed

628

Starts

2008-09-11

Expected to finish

2009-07-02

Last updated by the study team

2021-07-06

Who can join

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

You may qualify if…

• Males and non-fertile females.
• 18-75 years inclusive.
• Participants with mild-to-moderate uncomplicated essential hypertension.

You may not qualify if…

• All women of child bearing potential.
• Female participants 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 (New York Heart Association [NYHA] class II-IV).
• Cardiac electrical abnormalities indicating significant risk of safety for participant taking part 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 participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
• Participant 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 cytochrome P450 3A4 (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 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
• Serum sodium < 132 mEq/L at Visit 1.
• Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
• Bilirubin (total) > 1.5 x ULN at Visit 1.
• Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m\^2 at Visit 1.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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