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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are above target LDL-C and BP who are eligible for treatment

Exclusion Criteria:

  • High liver enzymes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3841018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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