This study is a proof-of-efficacy, dose finding study of LCI699 in patients with mild-to-moderate uncomplicated essential hypertension in order to assess whether the BP effect, safety and tolerability of LCI699 as compared to those of placebo…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the efficacy of any of 4 dose regimens (0.25 mg QD, 0.5mg QD, 1.0mg
QD and 0.5MG BID) of LIC699 in patients with essential hypertension by testing
the hypothesis that the reducation in mean sitting diastolic blood pressure
(MSDBP) 23-26 hours post dose (11-14 hours post BID dosing) with LCI699 is
superior to that with placebo after 8 weeks of treatment.
Secondary outcome
See protocol page 14, paragraph 3.2.
Background summary
High bloodpressure is a very common disease which is somtimes called 'silent
killer'. In this disease the bloodpressure within the bloodvessels is higher
than normal. Over times it leads to different secondary diseases in the
following organs: kidney, heart, bloodvessels, brain and eyes.
Study objective
This study is a proof-of-efficacy, dose finding study of LCI699 in patients
with mild-to-moderate uncomplicated essential hypertension in order to assess
whether the BP effect, safety and tolerability of LCI699 as compared to those
of placebo warrants continuation into the next development phase. This
assessment will be based on the consolidated evaluation of the tolerability
profile of LCI699 at all investigated doses and efficacy in BP reduction
compared to placebo and eplerenone. Eplerenone is selected as an active
comparator due to its relevant mechanism of aldesterone blockade.
Study design
A multi-center, randomized, double-blind, placebo and active controlled,
parallel group, dose finding study.
Intervention
All patients will receive placebo for 2 weeks. After that patients will be
treated with LCI 0.25mg Q.D., LCI 0.5 mg Q.D., LCI 1.0 mg Q.D., LCI 0.5mg
B.I.D., eplerenone 50mg B.I.D. or placebo. Finally, patients will be treated
with their original study medication or placebo for one week.
Study burden and risks
The study consists of 9 visits with the following measurements: physical
examination twice, APBM twice, ECG twice, bloodsamples 7 times and 3 times a
pregnancy test (if applicable). In 25% of the patients an extra bloodsample for
PK will be taken and two cortisol stimulation tests will be performed (during
each test two bloodsamples will be taken and an injection with cortisol will be
given).
Raapopseweg 1
6824 DP Arnhem
Nederland
Raapopseweg 1
6824 DP Arnhem
Nederland
Listed location countries
Age
Inclusion criteria
- Male, non-fertile female;
- Age from 18 up to 75 years inclusive;
- Mild to moderate uncomplicated essential hypertension
- MSDBP (Mean Seated Diastolic Blood Pressure) *95 mmg and *110 mmHg at visit 3.
Exclusion criteria
- Severe hypertension;
- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease;
- Type 1 or 2 diabetes mellitus;
- Previous or current diagnosis of congestive heart failure (NYHA class II-IV).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003139-19-NL |
| CCMO | NL24094.003.08 |