- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174304
Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia. (JEWEL II)
January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
1120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
- Pfizer Investigational Site
-
-
-
-
-
Salzburg, Austria, A-5020
- Pfizer Investigational Site
-
St. Poelten, Austria, A-3100
- Pfizer Investigational Site
-
Vienna, Austria, A-1090
- Pfizer Investigational Site
-
Wels, Austria, A-4600
- Pfizer Investigational Site
-
-
-
-
-
Bierbeek, Belgium, 3360
- Pfizer Investigational Site
-
Braine-L'Alleud, Belgium, 1420
- Pfizer Investigational Site
-
Brugge, Belgium, 8000
- Pfizer Investigational Site
-
De Pinte, Belgium, 9840
- Pfizer Investigational Site
-
Gozée, Belgium, 6534
- Pfizer Investigational Site
-
Seraing, Belgium, 4100
- Pfizer Investigational Site
-
Wemmel, Belgium, 1780
- Pfizer Investigational Site
-
Wilrijk, Belgium, 2610
- Pfizer Investigational Site
-
Zedelgem, Belgium, 8210
- Pfizer Investigational Site
-
-
-
-
-
Helsinki, Finland, 00260
- Pfizer Investigational Site
-
Kuopio, Finland, 70100
- Pfizer Investigational Site
-
Kuopio, Finland, 70110
- Pfizer Investigational Site
-
Oulu, Finland, 90100
- Pfizer Investigational Site
-
Oulu, Finland, 90150
- Pfizer Investigational Site
-
Tampere, Finland, 33210
- Pfizer Investigational Site
-
Turku, Finland, 20520
- Pfizer Investigational Site
-
Turku, Finland, 20360
- Pfizer Investigational Site
-
Vantaa, Finland, 01300
- Pfizer Investigational Site
-
-
-
-
-
Athens, Greece, 11527
- Pfizer Investigational Site
-
Ioannina, Greece, 45500
- Pfizer Investigational Site
-
Larissa, Greece, 41110
- Pfizer Investigational Site
-
Melissia, Greece, 15127
- Pfizer Investigational Site
-
Pireaus, Greece, 18526
- Pfizer Investigational Site
-
Rio, Patra, Greece, 26499
- Pfizer Investigational Site
-
Thessaloniki, Greece
- Pfizer Investigational Site
-
Thessaloniki, Greece, 54 639
- Pfizer Investigational Site
-
-
Crete
-
Heraklion, Crete, Greece, 71 110
- Pfizer Investigational Site
-
-
-
-
-
Budapest, Hungary, 1106
- Pfizer Investigational Site
-
Budapest, Hungary, 1115
- Pfizer Investigational Site
-
Budapest, Hungary, 1083
- Pfizer Investigational Site
-
Debrecen, Hungary, 4043
- Pfizer Investigational Site
-
Kecskemét, Hungary, 6000
- Pfizer Investigational Site
-
Miskolc, Hungary, 3526
- Pfizer Investigational Site
-
Mosonmagyaróvár, Hungary, 9200
- Pfizer Investigational Site
-
Pécs, Hungary, 7624
- Pfizer Investigational Site
-
Szekszárd, Hungary, 7100
- Pfizer Investigational Site
-
-
-
-
Wexford
-
Gorey, Wexford, Ireland
- Pfizer Investigational Site
-
New Ross, Wexford, Ireland
- Pfizer Investigational Site
-
-
-
-
-
Asti, Italy, 14100
- Pfizer Investigational Site
-
Bologna, Italy, 40139
- Pfizer Investigational Site
-
Bologna, Italy, 40133
- Pfizer Investigational Site
-
Bologna, Italy, 40126
- Pfizer Investigational Site
-
Bolzano, Italy, 39100
- Pfizer Investigational Site
-
Brescia, Italy, 25123
- Pfizer Investigational Site
-
Catania, Italy, 95123
- Pfizer Investigational Site
-
Catania, Italy, 95124
- Pfizer Investigational Site
-
Chieti, Italy, 66013
- Pfizer Investigational Site
-
Ferrara, Italy, 44100
- Pfizer Investigational Site
-
Firenze, Italy, 50139
- Pfizer Investigational Site
-
Foggia, Italy, 71100
- Pfizer Investigational Site
-
Genova, Italy, 16132
- Pfizer Investigational Site
-
Grosseto, Italy, 58100
- Pfizer Investigational Site
-
Napoli, Italy, 80131
- Pfizer Investigational Site
-
Novara, Italy, 28100
- Pfizer Investigational Site
-
Palermo, Italy, 90127
- Pfizer Investigational Site
-
Palermo, Italy, 90100
- Pfizer Investigational Site
-
Perugia, Italy, 06126
- Pfizer Investigational Site
-
Potenza, Italy, 85100
- Pfizer Investigational Site
-
Prato, Italy, 59100
- Pfizer Investigational Site
-
Roma, Italy, 00161
- Pfizer Investigational Site
-
Salerno, Italy, 84100
- Pfizer Investigational Site
-
Sassari, Italy, 07100
- Pfizer Investigational Site
-
Siena, Italy, 53100
- Pfizer Investigational Site
-
Torino, Italy, 10133
- Pfizer Investigational Site
-
Venezia, Italy, 30122
- Pfizer Investigational Site
-
-
(mi)
-
Vimercate, (mi), Italy, 20059
- Pfizer Investigational Site
-
-
(va)
-
Somma Lombardo, (va), Italy, 21019
- Pfizer Investigational Site
-
-
PG
-
San Sisto, PG, Italy, 06080
- Pfizer Investigational Site
-
-
VE
-
Mestre, VE, Italy, 30175
- Pfizer Investigational Site
-
-
-
-
-
Coimbra, Portugal, 3000
- Pfizer Investigational Site
-
Faro, Portugal, 8000
- Pfizer Investigational Site
-
Leiria, Portugal, 2410
- Pfizer Investigational Site
-
Lisboa, Portugal, 1300
- Pfizer Investigational Site
-
Lisboa, Portugal, 1990-050
- Pfizer Investigational Site
-
Lisbon, Portugal, 1169-024
- Pfizer Investigational Site
-
Porto, Portugal, 4000
- Pfizer Investigational Site
-
Porto, Portugal, 4050-113
- Pfizer Investigational Site
-
S. Martinho Do Bispo, Portugal, 3040
- Pfizer Investigational Site
-
Viana do Castelo, Portugal, 4900-858
- Pfizer Investigational Site
-
-
Penafiel
-
Guilhufe - PNF, Penafiel, Portugal, 4560-162
- Pfizer Investigational Site
-
-
Sra. Da Hora
-
Matosinhos, Sra. Da Hora, Portugal, 4464-513
- Pfizer Investigational Site
-
-
-
-
-
Izola, Slovenia, 6310
- Pfizer Investigational Site
-
Ljubljana, Slovenia, 1000
- Pfizer Investigational Site
-
Maribor, Slovenia, 2000
- Pfizer Investigational Site
-
-
-
-
-
Barcelona, Spain, 08036
- Pfizer Investigational Site
-
Barcelona, Spain, 08025
- Pfizer Investigational Site
-
Madrid, Spain, 28041
- Pfizer Investigational Site
-
Madrid, Spain, 28040
- Pfizer Investigational Site
-
-
Guipuzcoa
-
San Sebastian, Guipuzcoa, Spain, 20014
- Pfizer Investigational Site
-
-
Tarragona
-
Reus, Tarragona, Spain, 43201
- Pfizer Investigational Site
-
-
-
-
AG
-
Baden, AG, Switzerland, CH-5404
- Pfizer Investigational Site
-
-
BE
-
Bern, BE, Switzerland, CH-3010
- Pfizer Investigational Site
-
-
BS
-
Basel, BS, Switzerland, CH-4031
- Pfizer Investigational Site
-
-
SG
-
St. Gallen, SG, Switzerland, CH-9007
- Pfizer Investigational Site
-
-
TG
-
Münsterlingen, TG, Switzerland, CH-8596
- Pfizer Investigational Site
-
-
TI
-
Lugano, TI, Switzerland, CH-6900
- Pfizer Investigational Site
-
-
VD
-
Lausanne, VD, Switzerland, CH-1011
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines
Exclusion Criteria:
- High liver enzymes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hypertension
- Dyslipidemias
- Hyperlipidemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Atorvastatin
- Amlodipine
- Amlodipine, atorvastatin drug combination
Other Study ID Numbers
- A3841029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on Amlodipine/atorvastatin single pill
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHypertension | HyperlipidemiaBrazil, Turkey, Taiwan, Argentina, India, Philippines, Singapore, Thailand, Australia, Chile, South Africa, Jordan, Korea, Republic of, Lebanon, United Arab Emirates, Malaysia, Peru, Israel, Indonesia, Guatemala, Hong Kong, Kuwait, ... and more
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHypertension | DyslipidemiaUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHypertension | HypercholesterolemiaCosta Rica, Korea, Republic of, Panama, Turkey, Croatia, Taiwan, Dominican Republic, Thailand, Mexico, Russian Federation, Lebanon, United Arab Emirates, Malaysia, Philippines, Indonesia, Jordan, Czechia, Kuwait, Saudi Arabia, Venezuel...
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHypertension | HypercholesterolemiaJapan
-
Shanghai Jiao Tong University School of MedicineRecruitingHypertension | Atrial FibrillationChina
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHypertension | DyslipidemiaCanada, United Kingdom
-
Shanghai Jiao Tong University School of MedicineRecruitingIsolated Systolic HypertensionChina
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedAmlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)Hypertension | Angina Pectoris | Hypercholesterolemia | Familial Hypercholesterolemia
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHypertension | DyslipidemiaUnited States
-
Yerevan State Medical UniversityServierUnknownHypercholesterolemia | Essential Hypertension