to investigate in a descriptive way the dose-dependent effect of Olmesartan Medoxomil 20mg, 40mg en 80mg on arterial stiffness.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
to investigate in a descriptive way the dose-dependent effect of Olmesartan
Medoxomil 20mg, 40mg and 80mg on arterial stiffness assessed by:
• The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after
52 weeks of double-blind treatment
• The change from baseline in carotid-femoral PWV, after adjustment for change
from baseline in Mean Blood Pressure (MBP) after 52 weeks of double-blind
treatment
Secondary outcome
To investigate in a descriptive way the dose-dependent effect of Olmesartan
Medoxomil 20mg, 40mg and 80mg:
• The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after
24 weeks of double-blind treatment
• The change from baseline in carotid-femoral PWV, after adjustment for change
from baseline in Mean Blood Pressure (MBP) after 24 weeks of double-blind
treatment
• On Blood Pressure (BP) lowering, assessed by conventional BP measurement and
24h Ambulatory BP Measurement (24h-ABPM) after 52 and 24 weeks of double-blind
treatment
• On central Pulse Pressure (PP) and Augmentation Index (AI) after 52 and 24
weeks of double-blind treatment
• On common carotid stiffness, Intima-Media Thickness (IMT), and internal
diameter after 52 and 24 weeks of double-blind treatment.
Background summary
Olmesartan Medoxomil (OM) is an angiotensin II receptor antagonist developed
for administration by the oral route. It is a competitive and selective
blocker of the angiotensin II receptor subtype AT1.
OM in the form of 20 en 40 mg tablets have a proven clinical value in the the
treatment of hypertension; both the 20 and 40 mg tablets are registered
products in the European Union.
The current protocol is being conducted to evaluate the efficacy and safety of
3 doses of OM (20, 40 and 80 mg, in a forced titration period) on arterial
stiffness and thickness in subjects with metabolic syndrome.
Patients who suffer from metabolic syndrome will gain benefit from the use of
OM since the angiotensin II receptor slows down the factors that believe to
have an influence on arterial stiffness, which is a characteristic of metabolic
syndrome.
These patients will also benefit from the effect of the angiotensin II
suppression of the arterial stiffness due to the synergetic interaction between
angiotensine II en the insulin-activated conductivity in the muscular system
Study objective
to investigate in a descriptive way the dose-dependent effect of Olmesartan
Medoxomil 20mg, 40mg en 80mg on arterial stiffness.
Study design
This is a Phase 3b, multi-centre, double-blind, randomized, parallel-group
study, in which subjects will be assigned into three treatment groups and
receive either OM 20 mg, OM 40 mg, or OM 80 mg, once a day (o.d.) for 1 year,
in a forced titration design. Each group will receive OM 20 mg at baseline.
After one month, two-third of subjects will switch to OM 40 mg. After another
month, one-third of subjects will switch to OM 80 mg.
Intervention
1 tablet (OM 20 mg, or OM 40 mg or OM 80 mg) per day, for 1 year.
Study burden and risks
- the risk of hypotension (too low blood pressure) will be monitored and if
necessary a dose down-titration will be performed.
Down-titration can only be performed once, afterwards the patient will be
followed-up and is withdrawn from the trial.
- by confirmed hypertension during the trial, the subject might be excluded
from the study, if this is judged necessary for the subject's safety by the
investigator.
Zielstattstrasse 48
81379 Munchen
Duitsland
Zielstattstrasse 48
81379 Munchen
Duitsland
Listed location countries
Age
Inclusion criteria
- Age >= 18 and <= 75 years
- Hypertension and metabolic syndrome defined, according to the ATP III/ IDF 2005 and ESH/ESC 2007 definitions with modifications;
see Amended Protocol Version NL-1.0 page 25
Exclusion criteria
- Pregnant or lactating female;
- Type 1 and type 2 diabetes;
- *High range* mild hypertension;
- Moderate, severe, or resistant hypertension;
- Secondary hypertension of any aetiology;
- Kidney function impairment;
see protocol page 25 + see Substantial Amendment 1, page 6 of 9 + Substantial Amendment the Netherlands-specific 1, page 5 of 7 + Amended Protocol Version NL-1.0 page 26
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 | EUCTR2007-003131-23-NL |
| ClinicalTrials.gov | NCT00676845 |
| CCMO | NL23231.068.08 |