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NCT00330785 Clinical Trial

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

Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00330785
Other study ID # A3841018
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date September 2005

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 1250
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients who are above target LDL-C and BP who are eligible for treatment Exclusion Criteria: - High liver enzymes

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine/Atorvastatin

Locations
Country Name City State
Pfizer Investigational Site
Canada Pfizer Investigational Site Alymer Ontario
Canada Pfizer Investigational Site Antigonish Nova Scotia
Canada Pfizer Investigational Site Bonaventure Quebec
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Campbell River British Columbia
Canada Pfizer Investigational Site Charlottetown Prince Edward Island
Canada Pfizer Investigational Site Chilliwack British Columbia
Canada Pfizer Investigational Site Chomedy Quebec
Canada Pfizer Investigational Site Corunna Ontario
Canada Pfizer Investigational Site Digby Nova Scotia
Canada Pfizer Investigational Site Exeter Ontario
Canada Pfizer Investigational Site Gatineau Quebec
Canada Pfizer Investigational Site Granby Quebec
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Hamilton Ontario
Canada Pfizer Investigational Site Kingston Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Longueuil Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site New Westminster British Columbia
Canada Pfizer Investigational Site North Vancouver British Columbia
Canada Pfizer Investigational Site North York Ontario
Canada Pfizer Investigational Site North York Ontario
Canada Pfizer Investigational Site Oshawa Ontario
Canada Pfizer Investigational Site Oshawa Ontario
Canada Pfizer Investigational Site Peterborough Ontario
Canada Pfizer Investigational Site Pointe-Claire Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Quesnel British Columbia
Canada Pfizer Investigational Site Red Deer Alberta
Canada Pfizer Investigational Site Regina Saskatchewan
Canada Pfizer Investigational Site Rimouski
Canada Pfizer Investigational Site Sarnia Ontario
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site St Jerome Quebec
Canada Pfizer Investigational Site St-Gedeon Beauce
Canada Pfizer Investigational Site St-Georges Ouest Quebec
Canada Pfizer Investigational Site St-Marc Des Carrieres Quebec
Canada Pfizer Investigational Site St. John's
Canada Pfizer Investigational Site St. John's
Canada Pfizer Investigational Site St. John's
Canada Pfizer Investigational Site St. Lambert Quebec
Canada Pfizer Investigational Site Ste-foy Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Truro Nova Scotia
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Waterloo Ontario
Canada Pfizer Investigational Site Weston Ontario
Canada Pfizer Investigational Site Whitby Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
Canada Pfizer Investigational Site Winnipeg Manitoba
Canada Pfizer Investigational Site Wolfville Nova Scotia
United Kingdom Pfizer Investigational Site Aberdeen
United Kingdom Pfizer Investigational Site Angus Dundee
United Kingdom Pfizer Investigational Site Ayr Ayrshire
United Kingdom Pfizer Investigational Site Bangor, Belfast Northern Ireland
United Kingdom Pfizer Investigational Site Berkshire
United Kingdom Pfizer Investigational Site Blackpool Lancashire
United Kingdom Pfizer Investigational Site Bournemouth Dorset
United Kingdom Pfizer Investigational Site Cambridge
United Kingdom Pfizer Investigational Site Canterbury
United Kingdom Pfizer Investigational Site Canterbury Kent
United Kingdom Pfizer Investigational Site Central Milton Keyne England
United Kingdom Pfizer Investigational Site Coatbridge Scotland
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site Darlington County Durham
United Kingdom Pfizer Investigational Site Darlington County Durham
United Kingdom Pfizer Investigational Site Dorking
United Kingdom Pfizer Investigational Site Dundee
United Kingdom Pfizer Investigational Site Fowey Cornwall
United Kingdom Pfizer Investigational Site Frome Somerset
United Kingdom Pfizer Investigational Site Glasgow Scotland
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Hertfordshire
United Kingdom Pfizer Investigational Site Kent
United Kingdom Pfizer Investigational Site Lancaster England
United Kingdom Pfizer Investigational Site Leeds
United Kingdom Pfizer Investigational Site Leeds West Yorkshire
United Kingdom Pfizer Investigational Site Leigh-on-sea Essex
United Kingdom Pfizer Investigational Site Letchworth Hertfordshire
United Kingdom Pfizer Investigational Site Newcastle-upon-Tyne
United Kingdom Pfizer Investigational Site Newcastle-upon-Tyne
United Kingdom Pfizer Investigational Site nEWPORT gWENT
United Kingdom Pfizer Investigational Site Nottingham
United Kingdom Pfizer Investigational Site Paignton Devon
United Kingdom Pfizer Investigational Site Peterborough Cambs
United Kingdom Pfizer Investigational Site Plymouth Devon
United Kingdom Pfizer Investigational Site Rochdale
United Kingdom Pfizer Investigational Site Sandy Bedfordshire
United Kingdom Pfizer Investigational Site Sheffield Yorkshire
United Kingdom Pfizer Investigational Site Shrewsbury
United Kingdom Pfizer Investigational Site Spalding Lincolnshire
United Kingdom Pfizer Investigational Site Stairfoot, Barnsley South Yorkshire
United Kingdom Pfizer Investigational Site Stourbridge
United Kingdom Pfizer Investigational Site Surrey England
United Kingdom Pfizer Investigational Site Swanley
United Kingdom Pfizer Investigational Site Swindon
United Kingdom Pfizer Investigational Site Thornhill Cardiff
United Kingdom Pfizer Investigational Site Weybridge Surrey
United Kingdom Pfizer Investigational Site Whitstable Kent
United Kingdom Pfizer Investigational Site Wishaw, Lanarkshire England

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

Countries where clinical trial is conducted

Canada,  United Kingdom, 

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