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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758524
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : October 26, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: LCI699 Drug: Eplerenone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo

Active Comparator: Eplerenone Drug: Eplerenone
Experimental: LCI699 1 Drug: LCI699
Experimental: LCI699 2 Drug: LCI699
Experimental: LCI699 3 Drug: LCI699
Experimental: LCI699 4 Drug: LCI699

Primary Outcome Measures :
  1. Mean sitting diastolic blood pressure reduction [ Time Frame: After 8 weeks of double-blind treatment ]

Secondary Outcome Measures :
  1. Efficacy of mean sitting systolic blood pressure [ Time Frame: After 8 weeks of double-blind treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758524

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United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00758524    
Other Study ID Numbers: CLCI699A2201
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: May 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Essential hypertension
phase 2 study
antihypertensive agent
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents