HypertensionPhase 4JEWEL IINCT00174304
Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.
A Phase 4 study testing Amlodipine/atorvastatin single pill in people with Hypertension and Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 102 sites in 12 countries.
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, Hyperlipidemia
- What is being tested?
- Amlodipine/atorvastatin single pill
- Type of treatment
- Pill or oral medicine
- How many people
- 1,120 participants
- Where
- 102 sitesin 12 countries
- Study dates
- Oct 2004to Sep 2006
- Phase
- Phase 4
- 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
- Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines
Who cannot join
- High liver enzymes
Trial locations and contacts
102 sites in 12 countries.
102 sites in 12 countries
Italy31 sites
Pfizer Investigational Site
Asti, 14100
Pfizer Investigational Site
Bologna, 40126
Pfizer Investigational Site
Bologna, 40133
Pfizer Investigational Site
Bologna, 40139
Pfizer Investigational Site
Bolzano, 39100
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Catania, 95123
Pfizer Investigational Site
Catania, 95124
Pfizer Investigational Site
Chieti, 66013
Pfizer Investigational Site
Ferrara, 44100
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Foggia, 71100
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Grosseto, 58100
Pfizer Investigational Site
Mestre, VE, 30175
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Novara, 28100
Pfizer Investigational Site
Palermo, 90100
Pfizer Investigational Site
Palermo, 90127
Pfizer Investigational Site
Perugia, 06126
Pfizer Investigational Site
Potenza, 85100
Pfizer Investigational Site
Prato, 59100
Pfizer Investigational Site
Roma, 00161
Pfizer Investigational Site
Salerno, 84100
Pfizer Investigational Site
San Sisto, PG, 06080
Pfizer Investigational Site
Sassari, 07100
Pfizer Investigational Site
Siena, 53100
Pfizer Investigational Site
Somma Lombardo, (VA), 21019
Pfizer Investigational Site
Torino, 10133
Pfizer Investigational Site
Venezia, 30122
Pfizer Investigational Site
Vimercate, (MI), 20059
Portugal12 sites
Pfizer Investigational Site
Coimbra, 3000
Pfizer Investigational Site
Faro, 8000
Pfizer Investigational Site
Guilhufe - PNF, Penafiel, 4560-162
Pfizer Investigational Site
Leiria, 2410
Pfizer Investigational Site
Lisbon, 1169-024
Pfizer Investigational Site
Lisbon, 1300
Pfizer Investigational Site
Lisbon, 1990-050
Pfizer Investigational Site
Matosinhos Municipality, Sra. Da Hora, 4464-513
Pfizer Investigational Site
Porto, 4000
Pfizer Investigational Site
Porto, 4050-113
Pfizer Investigational Site
S. Martinho Do Bispo, 3040
Pfizer Investigational Site
Viana do Castelo, 4900-858
Belgium9 sites
Pfizer Investigational Site
Bierbeek, 3360
Pfizer Investigational Site
Braine-l'Alleud, 1420
Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
De Pinte, 9840
Pfizer Investigational Site
Gozée, 6534
Pfizer Investigational Site
Seraing, 4100
Pfizer Investigational Site
Wemmel, 1780
Pfizer Investigational Site
Wilrijk, 2610
Pfizer Investigational Site
Zedelgem, 8210
Finland9 sites
Pfizer Investigational Site
Helsinki, 00260
Pfizer Investigational Site
Kuopio, 70100
Pfizer Investigational Site
Kuopio, 70110
Pfizer Investigational Site
Oulu, 90100
Pfizer Investigational Site
Oulu, 90150
Pfizer Investigational Site
Tampere, 33210
Pfizer Investigational Site
Turku, 20360
Pfizer Investigational Site
Turku, 20520
Pfizer Investigational Site
Vantaa, 01300
Greece9 sites
Pfizer Investigational Site
Athens, 11527
Pfizer Investigational Site
Heraklion, Crete, 71 110
Pfizer Investigational Site
Ioannina, 45500
Pfizer Investigational Site
Larissa, 41110
Pfizer Investigational Site
Melíssia, 15127
Pfizer Investigational Site
Pireaus, 18526
Pfizer Investigational Site
Rio, Patra, 26499
Pfizer Investigational Site
Thessaloniki, 54 639
Pfizer Investigational Site
Thessaloniki
Hungary9 sites
Pfizer Investigational Site
Budapest, 1083
Pfizer Investigational Site
Budapest, 1106
Pfizer Investigational Site
Budapest, 1115
Pfizer Investigational Site
Debrecen, 4043
Pfizer Investigational Site
Kecskemét, 6000
Pfizer Investigational Site
Miskolc, 3526
Pfizer Investigational Site
Mosonmagyaróvár, 9200
Pfizer Investigational Site
Pécs, 7624
Pfizer Investigational Site
Szekszárd, 7100
Switzerland7 sites
Pfizer Investigational Site
Baden, Canton of Aargau, CH-5404
Pfizer Investigational Site
Basel, Canton of Basel-City, CH-4031
Pfizer Investigational Site
Bern, Canton of Bern, CH-3010
Pfizer Investigational Site
Lausanne, Canton of Vaud, CH-1011
Pfizer Investigational Site
Lugano, Canton Ticino, CH-6900
Pfizer Investigational Site
Münsterlingen, Thurgau, CH-8596
Pfizer Investigational Site
Sankt Gallen, Canton of St. Gallen, CH-9007
Spain6 sites
Pfizer Investigational Site
Barcelona, 08025
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Donostia / San Sebastian, Guipuzcoa, 20014
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Madrid, 28041
Pfizer Investigational Site
Reus, Tarragona, 43201
Austria4 sites
Pfizer Investigational Site
Salzburg, A-5020
Pfizer Investigational Site
Sankt Pölten, A-3100
Pfizer Investigational Site
Vienna, A-1090
Pfizer Investigational Site
Wels, A-4600
Slovenia3 sites
Pfizer Investigational Site
Izola, 6310
Pfizer Investigational Site
Ljubljana, 1000
Pfizer Investigational Site
Maribor, 2000
Ireland2 sites
Pfizer Investigational Site
Gorey, Wexford
Pfizer Investigational Site
New Ross, Wexford
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 II 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.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Amlodipine/atorvastatin single pill
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/atorvastatin single pillDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.
Secondary outcomes (1)
To asses changes since baseline of lab parameters, BP, safety of titration of amlodipine.atorvastatin to reach targets, to validate Expectations and Satisfaction with Treatment questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Study completionSep 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,120 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174304
- Sponsor's protocol ID
- A3841029
- Acronym
- JEWEL II
- Status last verified
- Jan 2021
- First submitted
- 9 Sep 2005
- 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
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 II Study)
- ClinicalTrials.gov ID
- NCT00174304
- Acronym / sponsor ID
- JEWEL II / A3841029
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,120 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 2006
- First posted
- 15 Sep 2005 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- 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)
- Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines
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 single pill | Drug | – |
Primary outcome
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.
1 secondary outcome
To asses changes since baseline of lab parameters, BP, safety of titration of amlodipine.atorvastatin to reach targets, to validate Expectations and Satisfaction with Treatment questionnaires.
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.
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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
102 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine/atorvastatin single pill in people with Hypertension and Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 102 sites in 12 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 102 sites in Italy, Portugal, Belgium, Finland, Greece and 6 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.. 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 NCT00174304, 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.