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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Amlodipine/atorvastatin single pill

Study Type

Interventional

Enrollment

1120

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

- - - Pfizer Investigational Site
Austria
- - Salzburg, Austria, A-5020
    - Pfizer Investigational Site
  - St. Poelten, Austria, A-3100
    - Pfizer Investigational Site
  - Vienna, Austria, A-1090
    - Pfizer Investigational Site
  - Wels, Austria, A-4600
    - Pfizer Investigational Site
Belgium
- - Bierbeek, Belgium, 3360
    - Pfizer Investigational Site
  - Braine-L'Alleud, Belgium, 1420
    - Pfizer Investigational Site
  - Brugge, Belgium, 8000
    - Pfizer Investigational Site
  - De Pinte, Belgium, 9840
    - Pfizer Investigational Site
  - GozÃ©e, Belgium, 6534
    - Pfizer Investigational Site
  - Seraing, Belgium, 4100
    - Pfizer Investigational Site
  - Wemmel, Belgium, 1780
    - Pfizer Investigational Site
  - Wilrijk, Belgium, 2610
    - Pfizer Investigational Site
  - Zedelgem, Belgium, 8210
    - Pfizer Investigational Site
Finland
- - Helsinki, Finland, 00260
    - Pfizer Investigational Site
  - Kuopio, Finland, 70100
    - Pfizer Investigational Site
  - Kuopio, Finland, 70110
    - Pfizer Investigational Site
  - Oulu, Finland, 90100
    - Pfizer Investigational Site
  - Oulu, Finland, 90150
    - Pfizer Investigational Site
  - Tampere, Finland, 33210
    - Pfizer Investigational Site
  - Turku, Finland, 20520
    - Pfizer Investigational Site
  - Turku, Finland, 20360
    - Pfizer Investigational Site
  - Vantaa, Finland, 01300
    - Pfizer Investigational Site
Greece
- - Athens, Greece, 11527
    - Pfizer Investigational Site
  - Ioannina, Greece, 45500
    - Pfizer Investigational Site
  - Larissa, Greece, 41110
    - Pfizer Investigational Site
  - Melissia, Greece, 15127
    - Pfizer Investigational Site
  - Pireaus, Greece, 18526
    - Pfizer Investigational Site
  - Rio, Patra, Greece, 26499
    - Pfizer Investigational Site
  - Thessaloniki, Greece
    - Pfizer Investigational Site
  - Thessaloniki, Greece, 54 639
    - Pfizer Investigational Site
- Crete
  - Heraklion, Crete, Greece, 71 110
    - Pfizer Investigational Site
Hungary
- - Budapest, Hungary, 1106
    - Pfizer Investigational Site
  - Budapest, Hungary, 1115
    - Pfizer Investigational Site
  - Budapest, Hungary, 1083
    - Pfizer Investigational Site
  - Debrecen, Hungary, 4043
    - Pfizer Investigational Site
  - KecskemÃ©t, Hungary, 6000
    - Pfizer Investigational Site
  - Miskolc, Hungary, 3526
    - Pfizer Investigational Site
  - MosonmagyarÃ³vÃ¡r, Hungary, 9200
    - Pfizer Investigational Site
  - PÃ©cs, Hungary, 7624
    - Pfizer Investigational Site
  - SzekszÃ¡rd, Hungary, 7100
    - Pfizer Investigational Site
Ireland
- Wexford
  - Gorey, Wexford, Ireland
    - Pfizer Investigational Site
  - New Ross, Wexford, Ireland
    - Pfizer Investigational Site
Italy
- - Asti, Italy, 14100
    - Pfizer Investigational Site
  - Bologna, Italy, 40139
    - Pfizer Investigational Site
  - Bologna, Italy, 40133
    - Pfizer Investigational Site
  - Bologna, Italy, 40126
    - Pfizer Investigational Site
  - Bolzano, Italy, 39100
    - Pfizer Investigational Site
  - Brescia, Italy, 25123
    - Pfizer Investigational Site
  - Catania, Italy, 95123
    - Pfizer Investigational Site
  - Catania, Italy, 95124
    - Pfizer Investigational Site
  - Chieti, Italy, 66013
    - Pfizer Investigational Site
  - Ferrara, Italy, 44100
    - Pfizer Investigational Site
  - Firenze, Italy, 50139
    - Pfizer Investigational Site
  - Foggia, Italy, 71100
    - Pfizer Investigational Site
  - Genova, Italy, 16132
    - Pfizer Investigational Site
  - Grosseto, Italy, 58100
    - Pfizer Investigational Site
  - Napoli, Italy, 80131
    - Pfizer Investigational Site
  - Novara, Italy, 28100
    - Pfizer Investigational Site
  - Palermo, Italy, 90127
    - Pfizer Investigational Site
  - Palermo, Italy, 90100
    - Pfizer Investigational Site
  - Perugia, Italy, 06126
    - Pfizer Investigational Site
  - Potenza, Italy, 85100
    - Pfizer Investigational Site
  - Prato, Italy, 59100
    - Pfizer Investigational Site
  - Roma, Italy, 00161
    - Pfizer Investigational Site
  - Salerno, Italy, 84100
    - Pfizer Investigational Site
  - Sassari, Italy, 07100
    - Pfizer Investigational Site
  - Siena, Italy, 53100
    - Pfizer Investigational Site
  - Torino, Italy, 10133
    - Pfizer Investigational Site
  - Venezia, Italy, 30122
    - Pfizer Investigational Site
- (mi)
  - Vimercate, (mi), Italy, 20059
    - Pfizer Investigational Site
- (va)
  - Somma Lombardo, (va), Italy, 21019
    - Pfizer Investigational Site
- PG
  - San Sisto, PG, Italy, 06080
    - Pfizer Investigational Site
- VE
  - Mestre, VE, Italy, 30175
    - Pfizer Investigational Site
Portugal
- - Coimbra, Portugal, 3000
    - Pfizer Investigational Site
  - Faro, Portugal, 8000
    - Pfizer Investigational Site
  - Leiria, Portugal, 2410
    - Pfizer Investigational Site
  - Lisboa, Portugal, 1300
    - Pfizer Investigational Site
  - Lisboa, Portugal, 1990-050
    - Pfizer Investigational Site
  - Lisbon, Portugal, 1169-024
    - Pfizer Investigational Site
  - Porto, Portugal, 4000
    - Pfizer Investigational Site
  - Porto, Portugal, 4050-113
    - Pfizer Investigational Site
  - S. Martinho Do Bispo, Portugal, 3040
    - Pfizer Investigational Site
  - Viana do Castelo, Portugal, 4900-858
    - Pfizer Investigational Site
- Penafiel
  - Guilhufe - PNF, Penafiel, Portugal, 4560-162
    - Pfizer Investigational Site
- Sra. Da Hora
  - Matosinhos, Sra. Da Hora, Portugal, 4464-513
    - Pfizer Investigational Site
Slovenia
- - Izola, Slovenia, 6310
    - Pfizer Investigational Site
  - Ljubljana, Slovenia, 1000
    - Pfizer Investigational Site
  - Maribor, Slovenia, 2000
    - Pfizer Investigational Site
Spain
- - Barcelona, Spain, 08036
    - Pfizer Investigational Site
  - Barcelona, Spain, 08025
    - Pfizer Investigational Site
  - Madrid, Spain, 28041
    - Pfizer Investigational Site
  - Madrid, Spain, 28040
    - Pfizer Investigational Site
- Guipuzcoa
  - San Sebastian, Guipuzcoa, Spain, 20014
    - Pfizer Investigational Site
- Tarragona
  - Reus, Tarragona, Spain, 43201
    - Pfizer Investigational Site
Switzerland
- AG
  - Baden, AG, Switzerland, CH-5404
    - Pfizer Investigational Site
- BE
  - Bern, BE, Switzerland, CH-3010
    - Pfizer Investigational Site
- BS
  - Basel, BS, Switzerland, CH-4031
    - Pfizer Investigational Site
- SG
  - St. Gallen, SG, Switzerland, CH-9007
    - Pfizer Investigational Site
- TG
  - MÃ¼nsterlingen, TG, Switzerland, CH-8596
    - Pfizer Investigational Site
- TI
  - Lugano, TI, Switzerland, CH-6900
    - Pfizer Investigational Site
- VD
  - Lausanne, VD, Switzerland, CH-1011
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A3841029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.