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ArtStiff: Olmesartan Medoxomil in Metabolic Syndrome
NCT00676845Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2008
- Primary completion
- May 2011
- Countries
- 3
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Modality
- Small Molecules
- Drugs
- olmesartan
- Conditions
- hypertension (HTN)
01
Overview
Phase 3, randomised, double-blind trial of olmesartan in hypertension (HTN) (3 arms), sponsored by Daiichi Sankyo Co., Ltd. Primary endpoints: Change from baseline in carotid-femoral pulse wave velocity at 1 year and Change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure at 1 year. Started Aug 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Low Dose
Olmesartan medoxomil lowest dosage for 52 weeks
Titration 1
Olmesartan medoxomil lowest dosage (4 weeks) -> higher dosage (48 weeks)
Titration 2
Olmesartan medoxomil lowest dosage (4 weeks) -> higher dosage (4 weeks) -> highest dosage (44 weeks)
03
Who it enrols
Patients with hypertension and metabolic syndrome, aged 18-75, without diabetes or severe hypertension.
04
Endpoints
Primary
Change from baseline in carotid-femoral pulse wave velocity
Change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure
Secondary
Blood pressure lowering assessed by conventional BP measurement and 24h ambulatory BP measurement
Central pulse pressure and augmentation index
Common carotid stiffness, intima-media thickness, and internal diameter
05
Results
Not all primary endpoints met
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