Clinical trial NCT01373086: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Keywords: Hypertension,
mild hypertension,
moderate hypertension,
high blood pressure,
uncomplicated hypertension.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment
timeFrame: Baseline, week 4
Secondary outcomes:
measure: Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment
timeFrame: Baseline, week 4
measure: Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment
timeFrame: Baseline, week 4
measure: Percentage of patients experiencing adverse events during the study as measure of safety and tolerability
timeFrame: 4 weeks
measure: Change from baseline in mean sitting SBP and DBP after 4 weeks treatment
timeFrame: Baseline, week 4
measure: Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)
timeFrame: 4 weeks
measure: change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment
timeFrame: Baseline, week 4
measure: Pharmacokinetics of LFF269: Plasma concentrations of LFF269
timeFrame: pre dose & 6 hours post study drug dose
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute-Phase I
state: California
city: Fort Myers
country: United States
facility: Comprehensive Phase I
state: Florida
city: Miramar
country: United States
facility: Comprehensive Phase One®,
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive NeuroScience
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Fremont
country: United States
facility: Clinical Research Advantage/ Prairie Fields Family Medicine, PC
state: Nebraska
city: Omaha
country: United States
facility: Internal Medicine Physicians
state: Nebraska
city: Omaha
country: United States
facility: ICON Developmental Solutions
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Advantage/ Aloha Medical
state: Nevada
city: San Antonio
country: United States
facility: ICON Development Solutions,
state: Texas
city: Tacoma
country: United States
facility: Comprehensive Clinical Development NW, Inc.
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: