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Nebivolol vs Metoprolol in Hypertensive Patients With PAD
NCT01499134Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2011
- Primary completion
- Jun 2014
- Countries
- 1
- Sponsor
- Thomas Jefferson University
- Modality
- Small Molecules
- Drugs
- nebivolol
- Conditions
- peripheral artery disease (PAD)hypertension (HTN)
01
Overview
Phase 3, randomised, double-blind trial of nebivolol in peripheral artery disease (PAD) and hypertension (HTN) (2 arms), sponsored by Thomas Jefferson University. Primary endpoint: Peak Walking Time at 26 weeks. Started Aug 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
nebivolol
nebivolol 1 to 4 capsules daily (max 20 mg)
metoprolol succinate
metoprolol succinate 1 to 4 capsules daily (max 200 mg)
03
Endpoints
Primary
Peak Walking Time
Secondary
Ankle-brachial Index
Claudication Onset Time
Walking Impairment Questionnaire - Change Calf Pain
Walking Impairment Questionnaire - Change in Buttock Pain
Walking Impairment Questionnaire - Change in WIQ Distance Score
Walking Impairment Questionnaire - Change in WIQ Speed Score
Walking Impairment Questionnaire - Change in WIQ Stairs Score
04
Results
Primary endpoints met
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