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Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia (JEWEL I)

Primary Purpose

Hypertension, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amlodipine/Atorvastatin
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: Patients who are above target LDL-C and BP who are eligible for treatment Exclusion Criteria: High liver enzymes

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

To evaluate the number of patients who reach target blood pressure (BP) and
LDL-C targets as defined by their governing guidelines.

Secondary Outcome Measures

To assess changes from baseline to end of treatment for the following efficacy
parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein
cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure
(SBP) and Diastolic Blood Pressue (DBP).

Full Information

First Posted
February 28, 2006
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
NCT00330785
Brief Title
Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia
Acronym
JEWEL I
Official Title
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL 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 2005 (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, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amlodipine/Atorvastatin
Primary Outcome Measure Information:
Title
To evaluate the number of patients who reach target blood pressure (BP) and
Title
LDL-C targets as defined by their governing guidelines.
Secondary Outcome Measure Information:
Title
To assess changes from baseline to end of treatment for the following efficacy
Title
parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein
Title
cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure
Title
(SBP) and Diastolic Blood Pressue (DBP).

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: Patients who are above target LDL-C and BP who are eligible for treatment 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
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3C3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2X 3X7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 7C4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4R 3J5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Campbell River
State/Province
British Columbia
ZIP/Postal Code
V9W 5Y4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chilliwack
State/Province
British Columbia
ZIP/Postal Code
V2P 4M9
Country
Canada
Facility Name
Pfizer Investigational Site
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
Pfizer Investigational Site
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7N 4M2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quesnel
State/Province
British Columbia
ZIP/Postal Code
V2J 2K3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5K 1K3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5P 3T7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J 1Z6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6M 3W7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 0R8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Antigonish
State/Province
Nova Scotia
ZIP/Postal Code
B2G 2C2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Digby
State/Province
Nova Scotia
ZIP/Postal Code
B0V 1A0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 5R3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Wolfville
State/Province
Nova Scotia
ZIP/Postal Code
B4P 1P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Alymer
State/Province
Ontario
ZIP/Postal Code
N5H 1K9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Exeter
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 1C2
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 1H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 4Y7
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5A5
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 4P2
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6P 1A9
Country
Canada
Facility Name
Pfizer Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J 1W8
Country
Canada
Facility Name
Pfizer Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3N 2V6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 5G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1W4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 5R5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bonaventure
State/Province
Quebec
ZIP/Postal Code
GOC 1E0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chomedy
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 6S9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4N 1E1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
St Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Pfizer Investigational Site
City
St-Georges Ouest
State/Province
Quebec
ZIP/Postal Code
G5Y 4W1
Country
Canada
Facility Name
Pfizer Investigational Site
City
St-Marc Des Carrieres
State/Province
Quebec
ZIP/Postal Code
G0A 4B0
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. Lambert
State/Province
Quebec
ZIP/Postal Code
J4P 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 3X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1J 1Z6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Rimouski
ZIP/Postal Code
G5L 9A8
Country
Canada
Facility Name
Pfizer Investigational Site
City
St-Gedeon Beauce
ZIP/Postal Code
G0M 1T0
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
ZIP/Postal Code
A1A 2E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
ZIP/Postal Code
A1B 3E4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ayr
State/Province
Ayrshire
ZIP/Postal Code
KA7 1BG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sandy
State/Province
Bedfordshire
ZIP/Postal Code
SG19 3JR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Peterborough
State/Province
Cambs
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Thornhill
State/Province
Cardiff
ZIP/Postal Code
CF14 9BB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Fowey
State/Province
Cornwall
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Darlington
State/Province
County Durham
ZIP/Postal Code
DL16 6QA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Darlington
State/Province
County Durham
ZIP/Postal Code
DL3 8SQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Paignton
State/Province
Devon
ZIP/Postal Code
TQ4 5LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3PY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH8 9EW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Angus
State/Province
Dundee
ZIP/Postal Code
DD1 5LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Central Milton Keyne
State/Province
England
ZIP/Postal Code
MK9 2NR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
England
ZIP/Postal Code
LA1 2LG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Surrey
State/Province
England
ZIP/Postal Code
CR7 7JN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wishaw, Lanarkshire
State/Province
England
ZIP/Postal Code
ML2 7BG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leigh-on-sea
State/Province
Essex
ZIP/Postal Code
SS9 2UW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
nEWPORT
State/Province
gWENT
ZIP/Postal Code
NP18 1AZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Letchworth
State/Province
Hertfordshire
ZIP/Postal Code
SG6 4UB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Whitstable
State/Province
Kent
ZIP/Postal Code
CT5 1BZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY4 3AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Spalding
State/Province
Lincolnshire
ZIP/Postal Code
PE11 2BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bangor, Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT19 1PP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coatbridge
State/Province
Scotland
ZIP/Postal Code
ML5 3EE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 1QW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Frome
State/Province
Somerset
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Stairfoot, Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S70 3RJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Weybridge
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS12 1JE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
Yorkshire
ZIP/Postal Code
S7 2DW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aberdeen
ZIP/Postal Code
AB15 4ZT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Berkshire
ZIP/Postal Code
SL2 1HD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cambridge
ZIP/Postal Code
CB5 8SP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Canterbury
ZIP/Postal Code
CT1 3HX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV 8LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV7 8LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dorking
ZIP/Postal Code
RH4 2BG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD2 5AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G20 7LR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
g31 1QS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G32 7JG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hertfordshire
ZIP/Postal Code
WD2 6EB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Kent
ZIP/Postal Code
TN10 3ET
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS25 1AN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE15 6TQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE5 2UY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nottingham
ZIP/Postal Code
NG4 3BP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Rochdale
ZIP/Postal Code
OL11 5AQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Shrewsbury
ZIP/Postal Code
SY2 6DL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Stourbridge
ZIP/Postal Code
DY8 1AW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swanley
ZIP/Postal Code
BR8 7AH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swindon
ZIP/Postal Code
SN25 4YZ
Country
United Kingdom
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=A3841018&StudyName=Open+Label+Study+Assessing+Effectiveness+Of+Amlodipine%2FAtorvastatin+In+Subjects+With+Hypertension+and+Dyslipidaemia+
Description
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Learn more about this trial

Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia

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