Clinical trial NCT00330785: Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_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:

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

Exclusion Criteria:

* High liver enzymes

Primary outcomes:
measure: To evaluate the number of patients who reach target blood pressure (BP) and
measure: LDL-C targets as defined by their governing guidelines.
Secondary outcomes:
measure: To assess changes from baseline to end of treatment for the following efficacy
measure: parameters: LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein
measure: cholesterol (HDL-C), HDL-C/LDL-C ratio, TC/HDL-C ratio. Systolic Blood Pressure
measure: (SBP) and Diastolic Blood Pressue (DBP).
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Campbell River
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Chilliwack
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: New Westminster
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: North Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Quesnel
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Antigonish
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Digby
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Wolfville
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Alymer
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Exeter
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North York
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North York
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Weston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Whitby
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Bonaventure
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Chomedy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Gatineau
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Granby
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St Jerome
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Georges Ouest
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Marc Des Carrieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St. Lambert
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Rimouski
country: Canada
facility: Pfizer Investigational Site
city: St-Gedeon Beauce
country: Canada
facility: Pfizer Investigational Site
city: St. John's
country: Canada
facility: Pfizer Investigational Site
city: St. John's
country: Canada
facility: Pfizer Investigational Site
city: St. John's
country: Canada
facility: Pfizer Investigational Site
city: Ayr
country: United Kingdom
facility: Pfizer Investigational Site
state: Ayrshire
city: Sandy
country: United Kingdom
facility: Pfizer Investigational Site
state: Bedfordshire
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambs
city: Thornhill
country: United Kingdom
facility: Pfizer Investigational Site
state: Cardiff
city: Fowey
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Darlington
country: United Kingdom
facility: Pfizer Investigational Site
state: County Durham
city: Darlington
country: United Kingdom
facility: Pfizer Investigational Site
state: County Durham
city: Paignton
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Bournemouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Dorset
city: Angus
country: United Kingdom
facility: Pfizer Investigational Site
state: Dundee
city: Central Milton Keyne
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Lancaster
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Surrey
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Wishaw, Lanarkshire
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Leigh-on-sea
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: nEWPORT
country: United Kingdom
facility: Pfizer Investigational Site
state: gWENT
city: Letchworth
country: United Kingdom
facility: Pfizer Investigational Site
state: Hertfordshire
city: Canterbury
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Whitstable
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Spalding
country: United Kingdom
facility: Pfizer Investigational Site
state: Lincolnshire
city: Bangor, Belfast
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Coatbridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Frome
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Stairfoot, Barnsley
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: Weybridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
city: Berkshire
country: United Kingdom
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
city: Canterbury
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Dorking
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Hertfordshire
country: United Kingdom
facility: Pfizer Investigational Site
city: Kent
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Rochdale
country: United Kingdom
facility: Pfizer Investigational Site
city: Shrewsbury
country: United Kingdom
facility: Pfizer Investigational Site
city: Stourbridge
country: United Kingdom
facility: Pfizer Investigational Site
city: Swanley
country: United Kingdom
facility: Pfizer Investigational Site
city: Swindon
country: United Kingdom
facility: Pfizer Investigational Site
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.