NCT00330785CompletedPhase 3
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.126 sites in 1 country1,250 target enrollmentStarted: October 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,250
- Locations
- 126
- Primary Endpoint
- LDL-C targets as defined by their governing guidelines.
Study Overview
Brief Summary
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are above target LDL-C and BP who are eligible for treatment
Exclusion Criteria
- •High liver enzymes
Outcomes
Primary Outcomes
LDL-C targets as defined by their governing guidelines.
To evaluate the number of patients who reach target blood pressure (BP) and
Secondary Outcomes
- parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein
- To assess changes from baseline to end of treatment for the following efficacy
- (SBP) and Diastolic Blood Pressue (DBP).
- cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure
Investigators
Study Sites (126)
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