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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

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: NCT00817635
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : December 4, 2012
Great Lakes Drug Development, Inc.
Information provided by (Responsible Party):

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in mean sitting systolic blood pressure (MSSBP) as measured by office blood pressure (OBP) [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :
  1. Change in mean sitting diastolic blood pressure (MSDBP) at 8 weeks as measured by OBP [ Time Frame: 8 weeks of treatment ]
  2. Proportion of patients achieving a successful BP response and BP control (MSSBP and MSDBP), as measured by OBP [ Time Frame: 8 weeks of treatment ]
  3. Dose/exposure BP response relationship of LCI699, as measured by OBP [ Time Frame: 8 weeks of treatment ]
  4. 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 ]
  5. To evaluate safety and tolerability of LCI699 [ Time Frame: 8 weeks of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00817635

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Sponsors and Collaborators
Great Lakes Drug Development, Inc.
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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 Identifier: NCT00817635    
Other Study ID Numbers: CLCI699A2216
EudraCT 2008-007338-23
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Keywords provided by Novartis:
Blood Pressure
Resistant Hypertension
Additional relevant MeSH terms:
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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