NCT00330785

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,250

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_3 hypertension

Geographic Reach
2 countries

125 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

First QC Date

February 28, 2006

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • To evaluate the number of patients who reach target blood pressure (BP) and

  • LDL-C targets as defined by their governing guidelines.

Secondary Outcomes (4)

  • 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).

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • High liver enzymes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (126)

Pfizer Investigational Site

Calgary, Alberta, T2N 2T8, Canada

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Pfizer Investigational Site

Calgary, Alberta, T2N 4N1, Canada

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Calgary, Alberta, T2S 3C3, Canada

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Calgary, Alberta, T2X 3X7, Canada

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Calgary, Alberta, T3E 7C4, Canada

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Red Deer, Alberta, T4R 3J5, Canada

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Campbell River, British Columbia, V9W 5Y4, Canada

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Chilliwack, British Columbia, V2P 4M9, Canada

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New Westminster, British Columbia, V3L 3W4, Canada

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North Vancouver, British Columbia, V7N 4M2, Canada

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Quesnel, British Columbia, V2J 2K3, Canada

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Vancouver, British Columbia, V5K 1K3, Canada

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Vancouver, British Columbia, V5P 3T7, Canada

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Vancouver, British Columbia, V5Z 4E1, Canada

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Vancouver, British Columbia, V6J 1Z6, Canada

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Vancouver, British Columbia, V6M 3W7, Canada

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Winnipeg, Manitoba, R2H 0R8, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Antigonish, Nova Scotia, B2G 2C2, Canada

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Digby, Nova Scotia, B0V 1A0, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3K 5R3, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Wolfville, Nova Scotia, B4P 1P4, Canada

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Alymer, Ontario, N5H 1K9, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Exeter, Ontario, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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Kingston, Ontario, K7L 1C2, Canada

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London, Ontario, N5W 1H4, Canada

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London, Ontario, N5W 6A2, Canada

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London, Ontario, N6A 4G5, Canada

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London, Ontario, N6C 4Y7, Canada

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London, Ontario, N6G 5A5, Canada

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London, Ontario, N6H 4P2, Canada

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London, Ontario, N6P 1A9, Canada

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North York, Ontario, M2J 1W8, Canada

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North York, Ontario, M3N 2V6, Canada

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Oshawa, Ontario, L1H 1C5, Canada

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Oshawa, Ontario, L1J 2K1, Canada

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Peterborough, Ontario, K9H 5G1, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Weston, Ontario, M9N 1W4, Canada

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Whitby, Ontario, L1N 5R5, Canada

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Charlottetown, Prince Edward Island, C1A 5N4, Canada

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Bonaventure, Quebec, GOC 1E0, Canada

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Chomedy, Quebec, H7T 2P5, Canada

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Gatineau, Quebec, J8Y 6S9, Canada

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Granby, Quebec, J2G 8Z9, Canada

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Longueuil, Quebec, J4N 1E1, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Québec, Quebec, G1J 1Z6, Canada

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Québec, Quebec, G1S 2L6, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Saint-Lambert, Quebec, J4P 2H4, Canada

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Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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St-Georges Ouest, Quebec, G5Y 4W1, Canada

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Ste-foy, Quebec, G1V 4G2, Canada

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Regina, Saskatchewan, S4P 3X3, Canada

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Rimouski, G5L 9A8, Canada

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St-Gedeon Beauce, G0M 1T0, Canada

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St. John's, A1A 2E2, Canada

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St. John's, A1A 3R5, Canada

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St. John's, A1B 3E4, Canada

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Pfizer Investigational Site

Ayr, Ayrshire, KA7 1BG, United Kingdom

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Sandy, Bedfordshire, SG19 3JR, United Kingdom

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Peterborough, Cambs, PE7 3JL, United Kingdom

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Thornhill, Cardiff, CF14 9BB, United Kingdom

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Fowey, Cornwall, PL23 1DT, United Kingdom

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Darlington, County Durham, DL16 6QA, United Kingdom

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Darlington, County Durham, DL3 8SQ, United Kingdom

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Paignton, Devon, TQ4 5LA, United Kingdom

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Plymouth, Devon, PL5 3PY, United Kingdom

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Bournemouth, Dorset, BH8 9EW, United Kingdom

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Angus, Dundee, DD1 5LA, United Kingdom

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Central Milton Keyne, England, MK9 2NR, United Kingdom

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Lancaster, England, LA1 2LG, United Kingdom

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Surrey, England, CR7 7JN, United Kingdom

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Wishaw, Lanarkshire, England, ML2 7BG, United Kingdom

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Leigh-on-Sea, Essex, SS9 2UW, United Kingdom

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Newport, gWENT, NP18 1AZ, United Kingdom

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Letchworth Garden City, Hertfordshire, SG6 4UB, United Kingdom

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Canterbury, Kent, CT1 3NG, United Kingdom

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Whitstable, Kent, CT5 1BZ, United Kingdom

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Blackpool, Lancashire, FY4 3AD, United Kingdom

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Spalding, Lincolnshire, PE11 2BH, United Kingdom

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Bangor, Belfast, Northern Ireland, BT19 1PP, United Kingdom

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Coatbridge, Scotland, ML5 3EE, United Kingdom

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Glasgow, Scotland, G31 1QW, United Kingdom

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Frome, Somerset, BA11 1EZ, United Kingdom

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Stairfoot, Barnsley, South Yorkshire, S70 3RJ, United Kingdom

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Weybridge, Surrey, KT15 2BH, United Kingdom

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Leeds, West Yorkshire, LS12 1JE, United Kingdom

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Sheffield, Yorkshire, S7 2DW, United Kingdom

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Aberdeen, AB15 4ZT, United Kingdom

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Berkshire, SL2 1HD, United Kingdom

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Cambridge, CB5 8SP, United Kingdom

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Canterbury, CT1 3HX, United Kingdom

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Coventry, CV 8LA, United Kingdom

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Coventry, CV7 8LA, United Kingdom

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Dorking, RH4 2BG, United Kingdom

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Dundee, DD2 5AD, United Kingdom

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Glasgow, G20 7LR, United Kingdom

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Glasgow, g31 1QS, United Kingdom

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Glasgow, G32 7JG, United Kingdom

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Hertfordshire, WD2 6EB, United Kingdom

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Kent, TN10 3ET, United Kingdom

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Leeds, LS25 1AN, United Kingdom

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Newcastle upon Tyne, NE15 6TQ, United Kingdom

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Newcastle upon Tyne, NE5 2UY, United Kingdom

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Nottingham, NG4 3BP, United Kingdom

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Rochdale, OL11 5AQ, United Kingdom

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Shrewsbury, SY2 6DL, United Kingdom

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Stourbridge, DY8 1AW, United Kingdom

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Swanley, BR8 7AH, United Kingdom

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Swindon, SN25 4YZ, United Kingdom

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Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

amlodipine, atorvastatin drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 28, 2006

First Posted

May 29, 2006

Study Start

October 1, 2004

Study Completion

September 1, 2005

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations