The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy variable is the change in PV from baseline as
assessed by 3 D ultrasonography after 78 weeks of double-blind
treatment with OM 20-40 mg daily compared to ATE 50-100 mg
daily.
Secondary outcome
Secondary efficacy variables:
Change from baseline PV at Week 52.
Percent change from baseline PV at Week 52 and at
Week 78.
Change from baseline SeDBP and SeSBP at Week 52 and at
Week 78.
Change from baseline PV after adjustment for change in
SeDBP and SeSBP at Week 52 and at Week 78.
Background summary
Anti-hypertensive therapy only is not sufficient in the treatment of
cardiovasculair diseases. A combination of anti-hypertensive therapy and
prevention or retard of atherosclerosis is considered more effective. OM is a
drug that lowers bloodpressure, but also has shown in experimental models that
it is effective against atherosclerosis. These experimental findings have to be
confirmed in humans.
The hypothesis of this study is: Is OM superior compared to ATE in regard to
the change from baseline in carotid plaque volume after 78 weeks of treatment.
Study objective
The primary efficacy variable is the change in PV from baseline as assessed by
3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg
daily compared to ATE 50-100 mg daily.
Secondary efficacy variables:
Change from baseline PV at Week 52.
Percent change from baseline PV at Week 52 and at
Week 78.
Change from baseline SeDBP and SeSBP at Week 52 and at
Week 78.
Change from baseline PV after adjustment for change in
SeDBP and SeSBP at Week 52 and at Week 78.
Study design
A randomised, double-blind, double-dummy, parallel-group,
multi-national, multi-centre trial.
Intervention
Subjects will be assigned to double-blind treatment groups with OM 20 mg
tablets o.d. or ATE
50 mg tablets o.d. (low dose) taken orally in the mornings with the option to
increase the dose to
OM 40 mg or ATE 100 mg (high dose) for subjects not achieving blood pressure
goal.
Study burden and risks
Medical history and background. Physical exam, bloed and urinetests at the
beginning and at the end of the study (2x). women with childbearing potential
need to underg a pregnancy test at the start and at the end of the study (2x).
Bloodpressure, heartrate and adverse event information will be done at every
visit (13x). Waist, bodyweight, 3 D ultrasonography and ECG will be done 3x.
All medication used in this trial are marketed products and the safety profile
is documented in the SmPCs.
Zielstattstrasse 48
81379 Munchen
Duitsland
Zielstattstrasse 48
81379 Munchen
Duitsland
Listed location countries
Age
Inclusion criteria
1. Male and female Caucasian outpatients aged > 40 years.
2. High BP defined as mean SeSBP/SeDBP * 140/90 mmHg.
3. One or more of the following additional risk factors:
* Smoking;
* Dyslipidaemia (high-density lipoprotein (HDL)-cholesterol < 0.9 mmol/L or low-density lipoprotein (LDL)-cholesterol > 2.6 mmol/L, or triglycerides > 1.7 mmol/L);
* Left ventricular hypertrophy;
* Cardiocerebrovascular events > 6 months ago;
* Presence of target organ damage.
4. Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV * 0.040 cm³ (* 40 µL) according to the measurements of EUTARC.
Exclusion criteria
1. Secondary or high grade hypertension including grade III hypertension (SeSBP of > 180 mmHg or SeDBP of > 105 mmHg).
2. Stroke, myocardial infarction within the previous 6 months.
3. Interventional or surgical vascular treatment within the previous 3 months.
4. Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy).
5. Symptomatic heart failure.
6. Diabetes.
7. Chronic obstructive pulmonary disease (COPD) or asthma.
8. Claudicatio intermittens stage II b or higher.
9. Clinical evidence of severe renal disease [including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of < 30 mL/min), macroalbuminuria (> 300 mg albumin/24 hours or 300 µg albumin/mg creatinine)].
10. Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months.
11. Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months.
12. Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia (< 50 beats/min at rest).
13. Known intolerance to study drugs.
14. Impaired liver function tests suggesting severe liver disorder.
15. Any life threatening disease.
16. Duplexsonographically determined stenosis of the common or internal carotid artery > 75%.
17. Plaque with marked shadowing from calcification.
18. Target plaques in CC artery extending into both internal and external arteries.
19. Pregnant or lactating female subjects.
20. Female subjects of childbearing potential without adequate contraception: intra-uterine devices, hormonal contraceptives, either oral, depot, patch or injectable and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. If a female becomes pregnant during the trial, she has to be withdrawn immediately (see section 9.4).
21. Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
22. Subject has previously entered this study.
23. Subjects who have received ATE within 30 days prior to entering the active treatment phase.
24. Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period.
25. Subjects with history of alcohol and or drug abuse.
26. Subjects with known malabsorption syndrome.
27. Subjects who had donated or lost 450 mL or more blood during the last three months before screening.
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 | EUCTR2009-013342-92-NL |
| CCMO | NL30204.068.09 |
| Other | Registratie is nog niet voltooid |