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A Study to Evaluate the Effects of LCI699 on Safety and Efficacy in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic

This study has been completed.
Sponsor:
Collaborators:
Great Lakes Drug Development, Inc.
Integrium
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00817635
First received: January 5, 2009
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will assess the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in patients with resistant hypertension.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Multi-center, Dose Ranging Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo After 8 Weeks Treatment in Patients With Resistant Hypertension

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in mean sitting systolic blood pressure (MSSBP) as measured by office blood pressure (OBP) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean sitting diastolic blood pressure (MSDBP) at 8 weeks as measured by OBP [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a successful BP response and BP control (MSSBP and MSDBP), as measured by OBP [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Dose/exposure BP response relationship of LCI699, as measured by OBP [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Changes from baseline in mean 24 hours, mean daytime and mean nighttime SBP and DBP, as measured by ABPM [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
  • To evaluate safety and tolerability of LCI699 [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: LCI699 dosing regimen 1 Drug: LCI699
Experimental: LCI699 dosing regimen 2 Drug: LCI699
Experimental: LCI699 dosing regimen 3 Drug: LCI699
Active Comparator: Eplerenone 50 mg BID Drug: Eplerenone

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Diagnosis of hypertension with MSSBP ≥ 140 mmHg and < 180 mmHg
  • Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
  • Male and female patients 18 to 75 years of age

Exclusion criteria:

  • Recent history of MI, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
  • Clinically significant ECG findings related to cardiac conduction defects
  • Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c > 9%)
  • Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817635

  Show 38 Study Locations
Sponsors and Collaborators
Novartis
Great Lakes Drug Development, Inc.
Integrium
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00817635     History of Changes
Other Study ID Numbers: CLCI699A2216, EudraCT 2008-007338-23
Study First Received: January 5, 2009
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration
Iceland: Icelandic Medicines Control Agency

Keywords provided by Novartis:
Blood Pressure
Hypertension
Resistant Hypertension

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 May 16, 2013