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

Tracking Information

First Received Date ^ICMJE

January 5, 2009

Last Updated Date

November 30, 2012

Start Date ^ICMJE

December 2008

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00817635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: LCI699
Drug: Placebo
Drug: Eplerenone

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

155

Completion Date

October 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Iceland

Administrative Information

NCT Number ^ICMJE

NCT00817635

Other Study ID Numbers ^ICMJE

CLCI699A2216, EudraCT 2008-007338-23

Has Data Monitoring Committee

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Great Lakes Drug Development, Inc.
Integrium

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2012

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

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