Hypertension
Conditions
Keywords
Hypertension,, mild hypertension,, moderate hypertension,, high blood pressure,, uncomplicated hypertension.
Brief summary
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment | Baseline, week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment | Baseline, week 4 | — |
| Percentage of patients experiencing adverse events during the study as measure of safety and tolerability | 4 weeks | 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 | Baseline, week 4 | — |
| Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment | Baseline, week 4 | — |
| change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment | Baseline, week 4 | — |
| Pharmacokinetics of LFF269: Plasma concentrations of LFF269 | pre dose & 6 hours post study drug dose | — |
| Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough) | 4 weeks | — |
Countries
United States
Outcome results
None listed