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Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.

An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia. (The JEWEL II Study)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00174304
Acronym
JEWEL II
Enrollment
1120
Registered
2005-09-15
Start date
2004-10-31
Completion date
2006-09-30
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hypertension

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.

Interventions

DRUGAmlodipine/atorvastatin single pill

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines

Exclusion criteria

* High liver enzymes

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.—

Secondary

MeasureTime frame
To asses changes since baseline of lab parameters, BP, safety of titration of amlodipine.atorvastatin to reach targets, to validate Expectations and Satisfaction with Treatment questionnaires.—

Countries

Austria, Belgium, Finland, Greece, Hungary, Ireland, Italy, Portugal, Slovenia, Spain, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026