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

Condition(s) targeted: Hypertension; Hyperlipidemia

Intervention: Amlodipine/atorvastatin single pill (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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.

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, St. Poelten A-3100, Austria

Pfizer Investigational Site, Wels A-4600, Austria

Pfizer Investigational Site, Vienna A-1090, Austria

Pfizer Investigational Site, Salzburg A-5020, Austria

Pfizer Investigational Site, Gozée 6534, Belgium

Pfizer Investigational Site, Braine-L'Alleud 1420, Belgium

Pfizer Investigational Site, Brugge 8000, Belgium

Pfizer Investigational Site, Wemmel 1780, Belgium

Pfizer Investigational Site, De Pinte 9840, Belgium

Pfizer Investigational Site, Wilrijk 2610, Belgium

Pfizer Investigational Site, Zedelgem 8210, Belgium

Pfizer Investigational Site, Bierbeek 3360, Belgium

Pfizer Investigational Site, Seraing 4100, Belgium

Pfizer Investigational Site, Turku 20520, Finland

Pfizer Investigational Site, Turku 20360, Finland

Pfizer Investigational Site, Helsinki 00260, Finland

Pfizer Investigational Site, Vantaa 01300, Finland

Pfizer Investigational Site, Tampere 33210, Finland

Pfizer Investigational Site, Oulu 90100, Finland

Pfizer Investigational Site, Oulu 90150, Finland

Pfizer Investigational Site, Kuopio 70110, Finland

Pfizer Investigational Site, Kuopio 70100, Finland

Pfizer Investigational Site, Ioannina 45500, Greece

Pfizer Investigational Site, Thessaloniki 54 639, Greece

Pfizer Investigational Site, Athens 11527, Greece

Pfizer Investigational Site, Pireaus 18526, Greece

Pfizer Investigational Site, Melissia 15127, Greece

Pfizer Investigational Site, Larissa 41110, Greece

Pfizer Investigational Site, Thessaloniki, Greece

Pfizer Investigational Site, Rio, Patra 26499, Greece

Pfizer Investigational Site, Kecskemét 6000, Hungary

Pfizer Investigational Site, Szekszárd 7100, Hungary

Pfizer Investigational Site, Miskolc 3526, Hungary

Pfizer Investigational Site, Mosonmagyaróvár 9200, Hungary

Pfizer Investigational Site, Budapest 1083, Hungary

Pfizer Investigational Site, Budapest 1115, Hungary

Pfizer Investigational Site, Pécs 7624, Hungary

Pfizer Investigational Site, Debrecen 4043, Hungary

Pfizer Investigational Site, Budapest 1106, Hungary

Pfizer Investigational Site, Unknown, Ireland

Pfizer Investigational Site, Firenze 50139, Italy

Pfizer Investigational Site, Brescia 25123, Italy

Pfizer Investigational Site, Venezia 30122, Italy

Pfizer Investigational Site, Roma 00161, Italy

Pfizer Investigational Site, SIENA 53100, Italy

Pfizer Investigational Site, Genova 16132, Italy

Pfizer Investigational Site, Bologna 40139, Italy

Pfizer Investigational Site, Catania 95124, Italy

Pfizer Investigational Site, Novara 28100, Italy

Pfizer Investigational Site, Prato 59100, Italy

Pfizer Investigational Site, Salerno 84100, Italy

Pfizer Investigational Site, Grosseto 58100, Italy

Pfizer Investigational Site, Perugia 06126, Italy

Pfizer Investigational Site, Foggia 71100, Italy

Pfizer Investigational Site, Bologna 40133, Italy

Pfizer Investigational Site, Palermo 90100, Italy

Pfizer Investigational Site, Ferrara 44100, Italy

Pfizer Investigational Site, Siena 53100, Italy

Pfizer Investigational Site, Catania 95123, Italy

Pfizer Investigational Site, Bolzano 39100, Italy

Pfizer Investigational Site, Chieti 66013, Italy

Pfizer Investigational Site, Palermo 90127, Italy

Pfizer Investigational Site, Asti 14100, Italy

Pfizer Investigational Site, Sassari 07100, Italy

Pfizer Investigational Site, Napoli 80131, Italy

Pfizer Investigational Site, Potenza 85100, Italy

Pfizer Investigational Site, Torino 10133, Italy

Pfizer Investigational Site, Bologna 40126, Italy

Pfizer Investigational Site, Porto 4000, Portugal

Pfizer Investigational Site, Lisboa 1300, Portugal

Pfizer Investigational Site, S. Martinho do Bispo 3040, Portugal

Pfizer Investigational Site, Coimbra 3000, Portugal

Pfizer Investigational Site, Faro 8000, Portugal

Pfizer Investigational Site, Viana do Castelo 4900-858, Portugal

Pfizer Investigational Site, Lisboa 1990-050, Portugal

Pfizer Investigational Site, Porto 4050-113, Portugal

Pfizer Investigational Site, Lisbon 1169-024, Portugal

Pfizer Investigational Site, Leiria 2410, Portugal

Pfizer Investigational Site, Ljubljana 1000, Slovenia

Pfizer Investigational Site, Maribor 2000, Slovenia

Pfizer Investigational Site, Izola 6310, Slovenia

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Barcelona 08025, Spain

Pfizer Investigational Site, Madrid 28040, Spain

Pfizer Investigational Site, Madrid 28041, Spain

Pfizer Investigational Site, Vimercate, (MI) 20059, Italy

Pfizer Investigational Site, Somma Lombardo, (VA) 21019, Italy

Pfizer Investigational Site, Baden, AG CH-5404, Switzerland

Pfizer Investigational Site, Bern, BE CH-3010, Switzerland

Pfizer Investigational Site, Basel, BS CH-4031, Switzerland

Pfizer Investigational Site, Unknown, CASCAIS 2750, Portugal

Pfizer Investigational Site, Heraklion, CRETE 71 110, Greece

Pfizer Investigational Site, Unknown, Genly 7040, Belgium

Pfizer Investigational Site, San Sebastian, Guipuzcoa 20014, Spain

Pfizer Investigational Site, SAN SISTO, PG 06080, Italy

Pfizer Investigational Site, Guilhufe - PNF, Penafiel 4560-162, Portugal

Pfizer Investigational Site, St. Gallen, SG CH-9007, Switzerland

Pfizer Investigational Site, Matosinhos, Sra. da Hora 4464-513, Portugal

Pfizer Investigational Site, Münsterlingen, TG CH-8596, Switzerland

Pfizer Investigational Site, Lugano, TI CH-6900, Switzerland

Pfizer Investigational Site, Reus, Tarragona 43201, Spain

Pfizer Investigational Site, Lausanne, VD CH-1011, Switzerland

Pfizer Investigational Site, Mestre, VE 30175, Italy

Pfizer Investigational Site, Gorey, WEXFORD, Ireland

Pfizer Investigational Site, New Ross, Wexford, Ireland

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

Link to ClinicalStudyResults.org posting

Starting date: October 2004
Ending date: September 2006
Last updated: April 17, 2007