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.
- Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP
and LDL-C not at target according to governing guidelines
- High liver enzymes
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia. | |||
| Official Title ICMJE | An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia. (The JEWEL II Study) | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Amlodipine/atorvastatin single pill | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Richard Hobbs FD, Gensini G, John Mancini GB, Manolis AJ, Bauer B, Genest J, Feldman RD, Harvey P, Jenssen TG, da Silva PM; JEWEL Study Group. International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: the JEWEL programme. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):472-80. doi: 10.1097/HJR.0b013e32832b63f5. | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 1120 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | September 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Austria, Belgium, Finland, Greece, Hungary, Ireland, Italy, Portugal, Slovenia, Spain, Switzerland | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00174304 | |||
| Other Study ID Numbers ICMJE | A3841029 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2007 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
