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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00758524
First received: September 23, 2008
Last updated: May 31, 2012
Last verified: May 2012
  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.


Condition Intervention Phase
Essential Hypertension
Drug: LCI699
Drug: Eplerenone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean sitting diastolic blood pressure reduction [ Time Frame: After 8 weeks of double-blind treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of mean sitting systolic blood pressure [ Time Frame: After 8 weeks of double-blind treatment ] [ Designated as safety issue: No ]

Enrollment: 526
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758524

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00758524     History of Changes
Other Study ID Numbers: CLCI699A2201
Study First Received: September 23, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
France: Agence Francaise de Securite Sanitaire des Produits de Sante
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Läkemedelsverket
Romania: National Medicines Agency
Netherlands: College ter Beoordeling van Geneesmiddelen
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Essential hypertension
phase 2 study
antihypertensive agent

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Eplerenone
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014