Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.

NCT00174304 | Completed Phase 4

• 1 other identifier: A3841029
• Study Type: interventional
• Target: 1,120
• Locations: 11 countries
• Sites: 101

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.

Conditions

Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Amlodipine/atorvastatin single pill DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines

You may not qualify if:

• High liver enzymes

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (102)

Pfizer Investigational Site

Salzburg, A-5020, Austria

Location

Pfizer Investigational Site

Sankt Pölten, A-3100, Austria

Location

Pfizer Investigational Site

Vienna, A-1090, Austria

Location

Pfizer Investigational Site

Wels, A-4600, Austria

Location

Pfizer Investigational Site

Bierbeek, 3360, Belgium

Location

Pfizer Investigational Site

Braine-l'Alleud, 1420, Belgium

Location

Pfizer Investigational Site

Bruges, 8000, Belgium

Location

Pfizer Investigational Site

De Pinte, 9840, Belgium

Location

Pfizer Investigational Site

Gozée, 6534, Belgium

Location

Pfizer Investigational Site

Seraing, 4100, Belgium

Location

Pfizer Investigational Site

Wemmel, 1780, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Zedelgem, 8210, Belgium

Location

Pfizer Investigational Site

Helsinki, 00260, Finland

Location

Pfizer Investigational Site

Kuopio, 70100, Finland

Location

Pfizer Investigational Site

Kuopio, 70110, Finland

Location

Pfizer Investigational Site

Oulu, 90100, Finland

Location

Pfizer Investigational Site

Oulu, 90150, Finland

Location

Pfizer Investigational Site

Tampere, 33210, Finland

Location

Pfizer Investigational Site

Turku, 20360, Finland

Location

Pfizer Investigational Site

Turku, 20520, Finland

Location

Pfizer Investigational Site

Vantaa, 01300, Finland

Location

Pfizer Investigational Site

Heraklion, Crete, 71 110, Greece

Location

Pfizer Investigational Site

Athens, 11527, Greece

Location

Pfizer Investigational Site

Ioannina, 45500, Greece

Location

Pfizer Investigational Site

Larissa, 41110, Greece

Location

Pfizer Investigational Site

Melíssia, 15127, Greece

Location

Pfizer Investigational Site

Pireaus, 18526, Greece

Location

Pfizer Investigational Site

Rio, Patra, 26499, Greece

Location

Pfizer Investigational Site

Thessaloniki, 54 639, Greece

Location

Pfizer Investigational Site

Thessaloniki, Greece

Location

Pfizer Investigational Site

Budapest, 1083, Hungary

Location

Pfizer Investigational Site

Budapest, 1106, Hungary

Location

Pfizer Investigational Site

Budapest, 1115, Hungary

Location

Pfizer Investigational Site

Debrecen, 4043, Hungary

Location

Pfizer Investigational Site

Kecskemét, 6000, Hungary

Location

Pfizer Investigational Site

Miskolc, 3526, Hungary

Location

Pfizer Investigational Site

Mosonmagyaróvár, 9200, Hungary

Location

Pfizer Investigational Site

Pécs, 7624, Hungary

Location

Pfizer Investigational Site

Szekszárd, 7100, Hungary

Location

Pfizer Investigational Site

Gorey, Wexford, Ireland

Location

Pfizer Investigational Site

New Ross, Wexford, Ireland

Location

Pfizer Investigational Site

Vimercate, (MI), 20059, Italy

Location

Pfizer Investigational Site

Somma Lombardo, (VA), 21019, Italy

Location

Pfizer Investigational Site

San Sisto, PG, 06080, Italy

Location

Pfizer Investigational Site

Mestre, VE, 30175, Italy

Location

Pfizer Investigational Site

Asti, 14100, Italy

Location

Pfizer Investigational Site

Bologna, 40126, Italy

Location

Pfizer Investigational Site

Bologna, 40133, Italy

Location

Pfizer Investigational Site

Bologna, 40139, Italy

Location

Pfizer Investigational Site

Bolzano, 39100, Italy

Location

Pfizer Investigational Site

Brescia, 25123, Italy

Location

Pfizer Investigational Site

Catania, 95123, Italy

Location

Pfizer Investigational Site

Catania, 95124, Italy

Location

Pfizer Investigational Site

Chieti, 66013, Italy

Location

Pfizer Investigational Site

Ferrara, 44100, Italy

Location

Pfizer Investigational Site

Florence, 50139, Italy

Location

Pfizer Investigational Site

Foggia, 71100, Italy

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Grosseto, 58100, Italy

Location

Pfizer Investigational Site

Napoli, 80131, Italy

Location

Pfizer Investigational Site

Novara, 28100, Italy

Location

Pfizer Investigational Site

Palermo, 90100, Italy

Location

Pfizer Investigational Site

Palermo, 90127, Italy

Location

Pfizer Investigational Site

Perugia, 06126, Italy

Location

Pfizer Investigational Site

Potenza, 85100, Italy

Location

Pfizer Investigational Site

Prato, 59100, Italy

Location

Pfizer Investigational Site

Roma, 00161, Italy

Location

Pfizer Investigational Site

Salerno, 84100, Italy

Location

Pfizer Investigational Site

Sassari, 07100, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Pfizer Investigational Site

Torino, 10133, Italy

Location

Pfizer Investigational Site

Venezia, 30122, Italy

Location

Pfizer Investigational Site

Guilhufe - PNF, Penafiel, 4560-162, Portugal

Location

Pfizer Investigational Site

Matosinhos Municipality, Sra. Da Hora, 4464-513, Portugal

Location

Pfizer Investigational Site

Coimbra, 3000, Portugal

Location

Pfizer Investigational Site

Faro, 8000, Portugal

Location

Pfizer Investigational Site

Leiria, 2410, Portugal

Location

Pfizer Investigational Site

Lisbon, 1169-024, Portugal

Location

Pfizer Investigational Site

Lisbon, 1300, Portugal

Location

Pfizer Investigational Site

Lisbon, 1990-050, Portugal

Location

Pfizer Investigational Site

Porto, 4000, Portugal

Location

Pfizer Investigational Site

Porto, 4050-113, Portugal

Location

Pfizer Investigational Site

S. Martinho Do Bispo, 3040, Portugal

Location

Pfizer Investigational Site

Viana do Castelo, 4900-858, Portugal

Location

Pfizer Investigational Site

Izola, 6310, Slovenia

Location

Pfizer Investigational Site

Ljubljana, 1000, Slovenia

Location

Pfizer Investigational Site

Maribor, 2000, Slovenia

Location

Pfizer Investigational Site

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Pfizer Investigational Site

Reus, Tarragona, 43201, Spain

Location

Pfizer Investigational Site

Barcelona, 08025, Spain

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Pfizer Investigational Site

Madrid, 28041, Spain

Location

Pfizer Investigational Site

Baden, Canton of Aargau, CH-5404, Switzerland

Location

Pfizer Investigational Site

Basel, Canton of Basel-City, CH-4031, Switzerland

Location

Pfizer Investigational Site

Bern, Canton of Bern, CH-3010, Switzerland

Location

Pfizer Investigational Site

Sankt Gallen, Canton of St. Gallen, CH-9007, Switzerland

Location

Pfizer Investigational Site

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Pfizer Investigational Site

Lugano, Canton Ticino, CH-6900, Switzerland

Location

Pfizer Investigational Site

Münsterlingen, Thurgau, CH-8596, Switzerland

Location

Pfizer Investigational Site

Location

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.

  PMID: 19407658 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2004
• Study Completion: September 1, 2006
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

IT (31); PT (12); ES (6); BE (9); IE (2); HU (9); FI (9); AU (4); SL (3); CH (7); GR (9)