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

NCT ID: NCT00174304

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-09-30

Brief Summary

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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

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Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Amlodipine/atorvastatin single pill

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Salzburg, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Wels, , Austria

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Bierbeek, , Belgium

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Braine-l'Alleud, , Belgium

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Bruges, , Belgium

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De Pinte, , Belgium

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Gozée, , Belgium

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Seraing, , Belgium

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Wemmel, , Belgium

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Wilrijk, , Belgium

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Zedelgem, , Belgium

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Helsinki, , Finland

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Kuopio, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Turku, , Finland

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Turku, , Finland

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Vantaa, , Finland

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Heraklion, Crete, Greece

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Athens, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Melíssia, , Greece

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Pireaus, , Greece

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Rio, Patra, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Mosonmagyaróvár, , Hungary

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Pécs, , Hungary

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Szekszárd, , Hungary

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Gorey, Wexford, Ireland

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New Ross, Wexford, Ireland

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Vimercate, (MI), Italy

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Somma Lombardo, (VA), Italy

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San Sisto, PG, Italy

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Mestre, VE, Italy

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Asti, , Italy

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Bologna, , Italy

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Bologna, , Italy

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Bologna, , Italy

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Bolzano, , Italy

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Brescia, , Italy

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Catania, , Italy

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Catania, , Italy

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Chieti, , Italy

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Ferrara, , Italy

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Florence, , Italy

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Foggia, , Italy

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Genova, , Italy

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Grosseto, , Italy

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Napoli, , Italy

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Novara, , Italy

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Palermo, , Italy

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Palermo, , Italy

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Perugia, , Italy

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Potenza, , Italy

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Prato, , Italy

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Roma, , Italy

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Salerno, , Italy

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Sassari, , Italy

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Siena, , Italy

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Torino, , Italy

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Venezia, , Italy

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Guilhufe - PNF, Penafiel, Portugal

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Matosinhos Municipality, Sra. Da Hora, Portugal

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Coimbra, , Portugal

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Faro, , Portugal

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Leiria, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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S. Martinho Do Bispo, , Portugal

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Viana do Castelo, , Portugal

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Izola, , Slovenia

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Ljubljana, , Slovenia

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Maribor, , Slovenia

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Donostia / San Sebastian, Guipuzcoa, Spain

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Reus, Tarragona, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Baden, Canton of Aargau, Switzerland

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Basel, Canton of Basel-City, Switzerland

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Bern, Canton of Bern, Switzerland

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Sankt Gallen, Canton of St. Gallen, Switzerland

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Lausanne, Canton of Vaud, Switzerland

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Lugano, Canton Ticino, Switzerland

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Münsterlingen, Thurgau, Switzerland

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, ,

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Countries

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Austria Belgium Finland Greece Hungary Ireland Italy Portugal Slovenia Spain Switzerland

References

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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.

Reference Type DERIVED
PMID: 19407658 (View on PubMed)

Related Links

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Other Identifiers

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A3841029

Identifier Type: -

Identifier Source: org_study_id

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