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

January 5, 2009
November 30, 2012
December 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00817635 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: LCI699
  • Drug: Placebo
  • Drug: Eplerenone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: LCI699 dosing regimen 1
    Intervention: Drug: LCI699
  • Experimental: LCI699 dosing regimen 2
    Intervention: Drug: LCI699
  • Experimental: LCI699 dosing regimen 3
    Intervention: Drug: LCI699
  • Active Comparator: Eplerenone 50 mg BID
    Intervention: Drug: Eplerenone
Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
October 2009
October 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Iceland
 
NCT00817635
CLCI699A2216, EudraCT 2008-007338-23
No
Novartis
Novartis
  • Great Lakes Drug Development, Inc.
  • Integrium
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP