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

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Amlodipine/atorvastatin single pill
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 9, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00174304
Brief Title
Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amlodipine/atorvastatin single pill
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Pfizer Investigational Site
City
St. Poelten
ZIP/Postal Code
A-3100
Country
Austria
Facility Name
Pfizer Investigational Site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
Pfizer Investigational Site
City
Bierbeek
ZIP/Postal Code
3360
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Braine-L'Alleud
ZIP/Postal Code
1420
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
De Pinte
ZIP/Postal Code
9840
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Seraing
ZIP/Postal Code
4100
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wemmel
ZIP/Postal Code
1780
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Zedelgem
ZIP/Postal Code
8210
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90150
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33210
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20360
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
Pfizer Investigational Site
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71 110
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Pfizer Investigational Site
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Pfizer Investigational Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Pfizer Investigational Site
City
Melissia
ZIP/Postal Code
15127
Country
Greece
Facility Name
Pfizer Investigational Site
City
Pireaus
ZIP/Postal Code
18526
Country
Greece
Facility Name
Pfizer Investigational Site
City
Rio, Patra
ZIP/Postal Code
26499
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
54 639
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gorey
State/Province
Wexford
Country
Ireland
Facility Name
Pfizer Investigational Site
City
New Ross
State/Province
Wexford
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Vimercate
State/Province
(mi)
ZIP/Postal Code
20059
Country
Italy
Facility Name
Pfizer Investigational Site
City
Somma Lombardo
State/Province
(va)
ZIP/Postal Code
21019
Country
Italy
Facility Name
Pfizer Investigational Site
City
San Sisto
State/Province
PG
ZIP/Postal Code
06080
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mestre
State/Province
VE
ZIP/Postal Code
30175
Country
Italy
Facility Name
Pfizer Investigational Site
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Pfizer Investigational Site
City
Salerno
ZIP/Postal Code
84100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Venezia
ZIP/Postal Code
30122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Guilhufe - PNF
State/Province
Penafiel
ZIP/Postal Code
4560-162
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Matosinhos
State/Province
Sra. Da Hora
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Faro
ZIP/Postal Code
8000
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Leiria
ZIP/Postal Code
2410
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1300
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1990-050
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisbon
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4000
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4050-113
Country
Portugal
Facility Name
Pfizer Investigational Site
City
S. Martinho Do Bispo
ZIP/Postal Code
3040
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Viana do Castelo
ZIP/Postal Code
4900-858
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Izola
ZIP/Postal Code
6310
Country
Slovenia
Facility Name
Pfizer Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Pfizer Investigational Site
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Pfizer Investigational Site
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Baden
State/Province
AG
ZIP/Postal Code
CH-5404
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Bern
State/Province
BE
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Basel
State/Province
BS
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
St. Gallen
State/Province
SG
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Münsterlingen
State/Province
TG
ZIP/Postal Code
CH-8596
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Lugano
State/Province
TI
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Lausanne
State/Province
VD
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Citations:
PubMed Identifier
19407658
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841029&StudyName=Open+Label+Study+To+Assess+The+Effectiveness+Of+Amlodipine%2DAtorvastatin+Combination+In+Hypertension+And+Dyslipidemia%2E
Description
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Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.

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