Clinical trial NCT00174304: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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 outcomes:
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.
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Pfizer Investigational Site
city: St. Poelten
country: Austria
facility: Pfizer Investigational Site
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Wels
country: Austria
facility: Pfizer Investigational Site
city: Bierbeek
country: Belgium
facility: Pfizer Investigational Site
city: Braine-L'Alleud
country: Belgium
facility: Pfizer Investigational Site
city: Brugge
country: Belgium
facility: Pfizer Investigational Site
city: De Pinte
country: Belgium
facility: Pfizer Investigational Site
city: GozÃ©e
country: Belgium
facility: Pfizer Investigational Site
city: Seraing
country: Belgium
facility: Pfizer Investigational Site
city: Wemmel
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Zedelgem
country: Belgium
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Vantaa
country: Finland
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
city: Larissa
country: Greece
facility: Pfizer Investigational Site
city: Melissia
country: Greece
facility: Pfizer Investigational Site
city: Pireaus
country: Greece
facility: Pfizer Investigational Site
city: Rio, Patra
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: KecskemÃ©t
country: Hungary
facility: Pfizer Investigational Site
city: Miskolc
country: Hungary
facility: Pfizer Investigational Site
city: MosonmagyarÃ³vÃ¡r
country: Hungary
facility: Pfizer Investigational Site
city: PÃ©cs
country: Hungary
facility: Pfizer Investigational Site
city: SzekszÃ¡rd
country: Hungary
facility: Pfizer Investigational Site
city: Gorey
country: Ireland
facility: Pfizer Investigational Site
state: Wexford
city: New Ross
country: Ireland
facility: Pfizer Investigational Site
state: Wexford
city: Vimercate
country: Italy
facility: Pfizer Investigational Site
state: (mi)
city: Somma Lombardo
country: Italy
facility: Pfizer Investigational Site
state: (va)
city: San Sisto
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Mestre
country: Italy
facility: Pfizer Investigational Site
state: VE
city: Asti
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bolzano
country: Italy
facility: Pfizer Investigational Site
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Chieti
country: Italy
facility: Pfizer Investigational Site
city: Ferrara
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Grosseto
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Novara
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Prato
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Salerno
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Venezia
country: Italy
facility: Pfizer Investigational Site
city: Guilhufe - PNF
country: Portugal
facility: Pfizer Investigational Site
state: Penafiel
city: Matosinhos
country: Portugal
facility: Pfizer Investigational Site
state: Sra. Da Hora
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Faro
country: Portugal
facility: Pfizer Investigational Site
city: Leiria
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisbon
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: S. Martinho Do Bispo
country: Portugal
facility: Pfizer Investigational Site
city: Viana do Castelo
country: Portugal
facility: Pfizer Investigational Site
city: Izola
country: Slovenia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Maribor
country: Slovenia
facility: Pfizer Investigational Site
city: San Sebastian
country: Spain
facility: Pfizer Investigational Site
state: Guipuzcoa
city: Reus
country: Spain
facility: Pfizer Investigational Site
state: Tarragona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Baden
country: Switzerland
facility: Pfizer Investigational Site
state: AG
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
state: BE
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
state: BS
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
state: SG
city: MÃ¼nsterlingen
country: Switzerland
facility: Pfizer Investigational Site
state: TG
city: Lugano
country: Switzerland
facility: Pfizer Investigational Site
state: TI
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
state: VD
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.