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

• ClinicalTrials.gov Identifier: NCT00174304
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: January 27, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: January 27, 2021
• Study Start Date: October 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 9, 2005): 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.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 9, 2005): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypertension
• Hyperlipidemia

• Intervention: Drug: Amlodipine/atorvastatin single pill
• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 9, 2005): 1120
• Original Enrollment: Same as current
• Study Completion Date: September 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Finland, Greece, Hungary, Ireland, Italy, Portugal, Slovenia, Spain, Switzerland

Administrative Information

• NCT Number: NCT00174304
• Other Study ID Numbers: A3841029
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021