HypertensionPhase 3JEWEL INCT00330785

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

A Phase 3 study testing Amlodipine/Atorvastatin in people with Hypertension and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 126 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension, Dyslipidemia
What is being tested?: Amlodipine/Atorvastatin
How many people: 1,250 participants
Where: 126 sitesin 3 countries
Study dates: Oct 2004to Sep 2005
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

High liver enzymes

Trial locations and contacts

126 sites in 3 countries.

Country

City, postcode or hospital

126 sites in 3 countries

Canada73 sites

Pfizer Investigational Site
Alymer, Ontario, N5H 1K9
Pfizer Investigational Site
Antigonish Nova Scotia, Nova Scotia, B2G 2C2
Pfizer Investigational Site
Bonaventure, Quebec, GOC 1E0
Pfizer Investigational Site
Calgary, Alberta, T2N 2T8
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1
Pfizer Investigational Site
Calgary, Alberta, T2S 3C3
Pfizer Investigational Site
Calgary, Alberta, T2X 3X7
Pfizer Investigational Site
Calgary, Alberta, T3E 7C4
Pfizer Investigational Site
Campbell River, British Columbia, V9W 5Y4
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 5N4
Pfizer Investigational Site
Chilliwack, British Columbia, V2P 4M9
Pfizer Investigational Site
Chomedy, Quebec, H7T 2P5
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Digby, Nova Scotia, B0V 1A0
Pfizer Investigational Site
Exeter, Ontario
Pfizer Investigational Site
Gatineau, Quebec, J8Y 6S9
Pfizer Investigational Site
Granby, Quebec, J2G 8Z9
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3K 5R3
Pfizer Investigational Site
Hamilton, Ontario, L8M 1K7
Pfizer Investigational Site
Kingston, Ontario, K7L 1C2
Pfizer Investigational Site
London, Ontario, N5W 1H4
Pfizer Investigational Site
London, Ontario, N5W 6A2
Pfizer Investigational Site
London, Ontario, N6A 4G5
Pfizer Investigational Site
London, Ontario, N6C 4Y7
Pfizer Investigational Site
London, Ontario, N6G 5A5
Pfizer Investigational Site
London, Ontario, N6H 4P2
Pfizer Investigational Site
London, Ontario, N6P 1A9
Pfizer Investigational Site
Longueuil, Quebec, J4N 1E1
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
New Westminster, British Columbia, V3L 3W4
Pfizer Investigational Site
North Vancouver, British Columbia, V7N 4M2
Pfizer Investigational Site
North York, Ontario, M2J 1W8
Pfizer Investigational Site
North York, Ontario, M3N 2V6
Pfizer Investigational Site
Oshawa, Ontario, L1H 1C5
Pfizer Investigational Site
Oshawa, Ontario, L1J 2K1
Pfizer Investigational Site
Peterborough, Ontario, K9H 5G1
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Québec, Quebec, G1J 1Z4
Pfizer Investigational Site
Québec, Quebec, G1J 1Z6
Pfizer Investigational Site
Québec, Quebec, G1S 2L6
Pfizer Investigational Site
Quesnel, British Columbia, V2J 2K3
Pfizer Investigational Site
Red Deer, Alberta, T4R 3J5
Pfizer Investigational Site
Regina, Saskatchewan, S4P 3X3
Pfizer Investigational Site
Rimouski, G5L 9A8
Pfizer Investigational Site
Saint-Jérôme, Quebec, J7Z 5T3
Pfizer Investigational Site
Saint-Lambert, Quebec, J4P 2H4
Pfizer Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
St-Gedeon Beauce, G0M 1T0
Pfizer Investigational Site
St-Georges Ouest, Quebec, G5Y 4W1
Pfizer Investigational Site
St. John's, A1A 2E2
Pfizer Investigational Site
St. John's, A1A 3R5
Pfizer Investigational Site
St. John's, A1B 3E4
Pfizer Investigational Site
Ste-foy, Quebec, G1V 4G2
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M4S 1Y2
Pfizer Investigational Site
Toronto, Ontario, M5G 2C4
Pfizer Investigational Site
Toronto, Ontario, M5T 3A9
Pfizer Investigational Site
Truro, Nova Scotia, B2N 1L2
Pfizer Investigational Site
Vancouver, British Columbia, V5K 1K3
Pfizer Investigational Site
Vancouver, British Columbia, V5P 3T7
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E1
Pfizer Investigational Site
Vancouver, British Columbia, V6J 1Z6
Pfizer Investigational Site
Vancouver, British Columbia, V6M 3W7
Pfizer Investigational Site
Waterloo, Ontario, N2J 1C4
Pfizer Investigational Site
Weston, Ontario, M9N 1W4
Pfizer Investigational Site
Whitby, Ontario, L1N 5R5
Pfizer Investigational Site
Winnipeg, Manitoba, R2H 0R8
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Pfizer Investigational Site
Wolfville, Nova Scotia, B4P 1P4

Other trials in Canada

United Kingdom52 sites

Pfizer Investigational Site
Aberdeen, AB15 4ZT
Pfizer Investigational Site
Angus, Dundee, DD1 5LA
Pfizer Investigational Site
Ayr, Ayrshire, KA7 1BG
Pfizer Investigational Site
Bangor, Belfast, Northern Ireland, BT19 1PP
Pfizer Investigational Site
Berkshire, SL2 1HD
Pfizer Investigational Site
Blackpool, Lancashire, FY4 3AD
Pfizer Investigational Site
Bournemouth, Dorset, BH8 9EW
Pfizer Investigational Site
Cambridge, CB5 8SP
Pfizer Investigational Site
Canterbury, Kent, CT1 3NG
Pfizer Investigational Site
Canterbury, CT1 3HX
Pfizer Investigational Site
Central Milton Keyne, England, MK9 2NR
Pfizer Investigational Site
Coatbridge, Scotland, ML5 3EE
Pfizer Investigational Site
Coventry, CV 8LA
Pfizer Investigational Site
Coventry, CV7 8LA
Pfizer Investigational Site
Darlington, County Durham, DL16 6QA
Pfizer Investigational Site
Darlington, County Durham, DL3 8SQ
Pfizer Investigational Site
Dorking, RH4 2BG
Pfizer Investigational Site
Dundee, DD2 5AD
Pfizer Investigational Site
Fowey, Cornwall, PL23 1DT
Pfizer Investigational Site
Frome, Somerset, BA11 1EZ
Pfizer Investigational Site
Glasgow, Scotland, G31 1QW
Pfizer Investigational Site
Glasgow, G20 7LR
Pfizer Investigational Site
Glasgow, g31 1QS
Pfizer Investigational Site
Glasgow, G32 7JG
Pfizer Investigational Site
Hertfordshire, WD2 6EB
Pfizer Investigational Site
Kent, TN10 3ET
Pfizer Investigational Site
Lancaster, England, LA1 2LG
Pfizer Investigational Site
Leeds, West Yorkshire, LS12 1JE
Pfizer Investigational Site
Leeds, LS25 1AN
Pfizer Investigational Site
Leigh-on-Sea, Essex, SS9 2UW
Pfizer Investigational Site
Letchworth Garden City, Hertfordshire, SG6 4UB
Pfizer Investigational Site
Newcastle upon Tyne, NE15 6TQ
Pfizer Investigational Site
Newcastle upon Tyne, NE5 2UY
Pfizer Investigational Site
Newport, gWENT, NP18 1AZ
Pfizer Investigational Site
Nottingham, NG4 3BP
Pfizer Investigational Site
Paignton, Devon, TQ4 5LA
Pfizer Investigational Site
Peterborough, Cambs, PE7 3JL
Pfizer Investigational Site
Plymouth, Devon, PL5 3PY
Pfizer Investigational Site
Rochdale, OL11 5AQ
Pfizer Investigational Site
Sandy, Bedfordshire, SG19 3JR
Pfizer Investigational Site
Sheffield, Yorkshire, S7 2DW
Pfizer Investigational Site
Shrewsbury, SY2 6DL
Pfizer Investigational Site
Spalding, Lincolnshire, PE11 2BH
Pfizer Investigational Site
Stairfoot, Barnsley, South Yorkshire, S70 3RJ
Pfizer Investigational Site
Stourbridge, DY8 1AW
Pfizer Investigational Site
Surrey, England, CR7 7JN
Pfizer Investigational Site
Swanley, BR8 7AH
Pfizer Investigational Site
Swindon, SN25 4YZ
Pfizer Investigational Site
Thornhill, Cardiff, CF14 9BB
Pfizer Investigational Site
Weybridge, Surrey, KT15 2BH
Pfizer Investigational Site
Whitstable, Kent, CT5 1BZ
Pfizer Investigational Site
Wishaw, Lanarkshire, England, ML2 7BG

Other trials in United Kingdom

Location not given1 site

Pfizer Investigational Site

About this study

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)

Conditions: Hypertension, Dyslipidemia
Being tested: Amlodipine/Atorvastatin
Medical subject headings: Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine/AtorvastatinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Sep 2005

First posted29 May 2006 (estimated)
Study startOct 2004
Study completionSep 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,250 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00330785
Sponsor's protocol ID: A3841018
Acronym: JEWEL I
Status last verified: Jan 2021
First submitted: 28 Feb 2006
Last updated: 27 Jan 2021
Results posted: No

Publications

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.
PubMed 19407658

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00330785
Acronym / sponsor ID: JEWEL I / A3841018
Conditions: Hypertension, Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,250 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2004
Study completion: Sep 2005
First posted: 29 May 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

High liver enzymes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine/Atorvastatin	Drug	–

Primary outcome

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

4 secondary outcomes

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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Derived from this study: PubMed 19407658Richard 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

126 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlodipine/Atorvastatin in people with Hypertension and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 126 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the number of patients who reach target blood pressure (BP) and. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00330785, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.