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JEWEL II: Amlodipine/Atorvastatin in Hypertension and Dyslipidemia
NCT00174304Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2004
- Countries
- 11
- Sponsor
- Viatris
- Modality
- Small Molecules
- Conditions
- hypertension (HTN)dyslipidemia
01
Overview
Phase 4, open-label, single-arm trial of amlodipine and atorvastatin in hypertension (HTN) and dyslipidemia, sponsored by Viatris. Primary endpoint: Percentage of subjects who reach target BP and LDL-C targets. Started Oct 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Amlodipine/atorvastatin single pill
Single-pill combination of amlodipine and atorvastatin.
03
Who it enrols
Patients with concurrent hypertension and dyslipidemia not at target BP and LDL-C levels according to governing guidelines; excludes those with high liver enzymes.
04
Endpoints
Primary
Percentage of subjects who reach target BP and LDL-C targets
Secondary
Changes since baseline of lab parameters
Changes since baseline of blood pressure
Safety of titration of amlodipine/atorvastatin to reach targets
Expectations and Satisfaction with Treatment questionnaires
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