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NCT00174304 Clinical Trial

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

Hypertension Clinical Trial

— JEWEL II  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174304
Other study ID # A3841029
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2004
Est. completion date September 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1120
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine/atorvastatin single pill

Locations
Country Name City State
Pfizer Investigational Site
Austria Pfizer Investigational Site Salzburg
Austria Pfizer Investigational Site St. Poelten
Austria Pfizer Investigational Site Vienna
Austria Pfizer Investigational Site Wels
Belgium Pfizer Investigational Site Bierbeek
Belgium Pfizer Investigational Site Braine-L'Alleud
Belgium Pfizer Investigational Site Brugge
Belgium Pfizer Investigational Site De Pinte
Belgium Pfizer Investigational Site Gozée
Belgium Pfizer Investigational Site Seraing
Belgium Pfizer Investigational Site Wemmel
Belgium Pfizer Investigational Site Wilrijk
Belgium Pfizer Investigational Site Zedelgem
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Tampere
Finland Pfizer Investigational Site Turku
Finland Pfizer Investigational Site Turku
Finland Pfizer Investigational Site Vantaa
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Heraklion Crete
Greece Pfizer Investigational Site Ioannina
Greece Pfizer Investigational Site Larissa
Greece Pfizer Investigational Site Melissia
Greece Pfizer Investigational Site Pireaus
Greece Pfizer Investigational Site Rio, Patra
Greece Pfizer Investigational Site Thessaloniki
Greece Pfizer Investigational Site Thessaloniki
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Debrecen
Hungary Pfizer Investigational Site Kecskemét
Hungary Pfizer Investigational Site Miskolc
Hungary Pfizer Investigational Site Mosonmagyaróvár
Hungary Pfizer Investigational Site Pécs
Hungary Pfizer Investigational Site Szekszárd
Ireland Pfizer Investigational Site Gorey Wexford
Ireland Pfizer Investigational Site New Ross Wexford
Italy Pfizer Investigational Site Asti
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Bolzano
Italy Pfizer Investigational Site Brescia
Italy Pfizer Investigational Site Catania
Italy Pfizer Investigational Site Catania
Italy Pfizer Investigational Site Chieti
Italy Pfizer Investigational Site Ferrara
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Foggia
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Grosseto
Italy Pfizer Investigational Site Mestre VE
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Novara
Italy Pfizer Investigational Site Palermo
Italy Pfizer Investigational Site Palermo
Italy Pfizer Investigational Site Perugia
Italy Pfizer Investigational Site Potenza
Italy Pfizer Investigational Site Prato
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Salerno
Italy Pfizer Investigational Site San Sisto PG
Italy Pfizer Investigational Site Sassari
Italy Pfizer Investigational Site Siena
Italy Pfizer Investigational Site Somma Lombardo (va)
Italy Pfizer Investigational Site Torino
Italy Pfizer Investigational Site Venezia
Italy Pfizer Investigational Site Vimercate (mi)
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Faro
Portugal Pfizer Investigational Site Guilhufe - PNF Penafiel
Portugal Pfizer Investigational Site Leiria
Portugal Pfizer Investigational Site Lisboa
Portugal Pfizer Investigational Site Lisboa
Portugal Pfizer Investigational Site Lisbon
Portugal Pfizer Investigational Site Matosinhos Sra. Da Hora
Portugal Pfizer Investigational Site Porto
Portugal Pfizer Investigational Site Porto
Portugal Pfizer Investigational Site S. Martinho Do Bispo
Portugal Pfizer Investigational Site Viana do Castelo
Slovenia Pfizer Investigational Site Izola
Slovenia Pfizer Investigational Site Ljubljana
Slovenia Pfizer Investigational Site Maribor
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Reus Tarragona
Spain Pfizer Investigational Site San Sebastian Guipuzcoa
Switzerland Pfizer Investigational Site Baden AG
Switzerland Pfizer Investigational Site Basel BS
Switzerland Pfizer Investigational Site Bern BE
Switzerland Pfizer Investigational Site Lausanne VD
Switzerland Pfizer Investigational Site Lugano TI
Switzerland Pfizer Investigational Site Münsterlingen TG
Switzerland Pfizer Investigational Site St. Gallen SG

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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.
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