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LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LFF269
Eplerenone
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension,, mild hypertension,, moderate hypertension,, high blood pressure,, uncomplicated hypertension.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female (post-menopausal or surgically sterile).
  2. Age from 18 to 75 years inclusive.
  3. Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
  4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.

Exclusion Criteria:

  1. History or evidence of a secondary form of hypertension,
  2. History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
  3. Clinically significant valvular heart disease.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Advanced Clinical Research Institute-Phase I
  • Comprehensive Phase I
  • Comprehensive Phase One®,
  • Comprehensive NeuroScience
  • Clinical Research Atlanta
  • Clinical Research Advantage/ Prairie Fields Family Medicine, PC
  • Internal Medicine Physicians
  • ICON Developmental Solutions
  • Clinical Research Advantage/ Aloha Medical
  • ICON Development Solutions,
  • Comprehensive Clinical Development NW, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

LFF269 low dose

LFF269 high dose

Eplerenone

Placebo

Arm Description

LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period

LFF269 high dose + Matching Placebo to Eplerenone 50mg

Eplerenone 50mg twice daily + matching placebo of LFF269

Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg

Outcomes

Primary Outcome Measures

Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment

Secondary Outcome Measures

Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment
Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment
Percentage of patients experiencing adverse events during the study as measure of safety and tolerability
Adverse events will be reported as percentage of patients with total adverse events, serious adverse events and death.
Change from baseline in mean sitting SBP and DBP after 4 weeks treatment
Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)
change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment
Pharmacokinetics of LFF269: Plasma concentrations of LFF269

Full Information

First Posted
May 24, 2011
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01373086
Brief Title
LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
Official Title
A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Proof-of-concept Study to Evaluate the Efficacy and Safety of LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension,, mild hypertension,, moderate hypertension,, high blood pressure,, uncomplicated hypertension.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFF269 low dose
Arm Type
Experimental
Arm Description
LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period
Arm Title
LFF269 high dose
Arm Type
Experimental
Arm Description
LFF269 high dose + Matching Placebo to Eplerenone 50mg
Arm Title
Eplerenone
Arm Type
Active Comparator
Arm Description
Eplerenone 50mg twice daily + matching placebo of LFF269
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg
Intervention Type
Drug
Intervention Name(s)
LFF269
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment
Time Frame
Baseline, week 4
Secondary Outcome Measure Information:
Title
Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment
Time Frame
Baseline, week 4
Title
Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment
Time Frame
Baseline, week 4
Title
Percentage of patients experiencing adverse events during the study as measure of safety and tolerability
Description
Adverse events will be reported as percentage of patients with total adverse events, serious adverse events and death.
Time Frame
4 weeks
Title
Change from baseline in mean sitting SBP and DBP after 4 weeks treatment
Time Frame
Baseline, week 4
Title
Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)
Time Frame
4 weeks
Title
change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment
Time Frame
Baseline, week 4
Title
Pharmacokinetics of LFF269: Plasma concentrations of LFF269
Time Frame
pre dose & 6 hours post study drug dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female (post-menopausal or surgically sterile). Age from 18 to 75 years inclusive. Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2. Exclusion Criteria: History or evidence of a secondary form of hypertension, History of cardiovascular disease. Type 1 or type 2 diabetes mellitus. Clinically significant valvular heart disease. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Research Institute-Phase I
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Comprehensive Phase I
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
333901
Country
United States
Facility Name
Comprehensive Phase One®,
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Comprehensive NeuroScience
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Clinical Research Advantage/ Prairie Fields Family Medicine, PC
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Internal Medicine Physicians
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
ICON Developmental Solutions
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
Clinical Research Advantage/ Aloha Medical
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89183
Country
United States
Facility Name
ICON Development Solutions,
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Comprehensive Clinical Development NW, Inc.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7184
Description
Results for CLFF269X2201 from the Novartis Clinical Trials website

Learn more about this trial

LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

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