Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
NCT ID: NCT00407537
Last Updated: 2021-01-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
1531 participants
INTERVENTIONAL
2007-03-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Caduet
Open label caduet added to usual care regimen followed by investigators.
Amlodipine besylate/atorvastatin calcium single pill combination
Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Interventions
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Amlodipine besylate/atorvastatin calcium single pill combination
Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
35 Years
79 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Desamparados, Provincia de San José, Costa Rica
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Heredia, , Costa Rica
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San José, , Costa Rica
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Breznički Hum, , Croatia
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Crikvenica, , Croatia
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Čakovec, , Croatia
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Karlovac, , Croatia
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Rijeka, , Croatia
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Split, , Croatia
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Sveti Križ Začretje, , Croatia
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Špišić-Bukovica, , Croatia
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Varaždin, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
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Klatovy, , Czechia
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Kralupy nad Vltavou, , Czechia
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Lanškroun, , Czechia
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Olomouc, , Czechia
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Pelhřimov, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Průhonice, , Czechia
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Ústí nad Labem, , Czechia
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Vratimov, , Czechia
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Zlín, , Czechia
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San Cristóbal, , Dominican Republic
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Santo Domingo, , Dominican Republic
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Santo Domingo, , Dominican Republic
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Cilandak, Jakarta Selatan, Indonesia
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Bandung, , Indonesia
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Jakarta, , Indonesia
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Jakarta, , Indonesia
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Semarang, , Indonesia
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Surabaya, , Indonesia
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Tangerang, , Indonesia
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Tanggerang, , Indonesia
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Amman, , Jordan
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Amman, , Jordan
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Irbid, , Jordan
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Kuwait City, , Kuwait
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Sasat, , Kuwait
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Beirut, , Lebanon
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Byblos, , Lebanon
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Kuala Pilah, Negeri Sembilan, Malaysia
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Seremban, Negeri Sembilan, Malaysia
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Batu Caves, Selangor, Malaysia
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Petaling Jaya, Selangor, Malaysia
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Butterworth, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Toluca, State of Mexico, Mexico
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Durango, , Mexico
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San Luis Potosí City, , Mexico
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Panama City, , Panama
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San Juan City, National Capital Region, Philippines
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Makati City, , Philippines
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Manila, , Philippines
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Marikina City, , Philippines
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Quezon City, , Philippines
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Volgograd, , Russia
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Voronezh, , Russia
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Riyadh, , Saudi Arabia
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Wŏnju, Gangwon-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Gwangju, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Rajthevee, Bangkok, Thailand
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Saimai, Bangkok, Thailand
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Bangkok, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Abu Dhabi, , United Arab Emirates
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Al Ain City, , United Arab Emirates
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Dubai, , United Arab Emirates
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Naguanagua/Valencia, Carabobo, Venezuela
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Valencia, Carabobo, Venezuela
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Caracas, Dtto Capital/Municipio Libertador, Venezuela
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Caracas, Dtto Capital/Municipio Libertador, Venezuela
Countries
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References
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Cho EJ, Kim JH, Sutradhar S, Yunis C, Westergaard M; CRUCIAL Trial Investigators. Proactive multifactorial intervention strategy reduces the risk of cardiovascular disease estimated with region-specific risk assessment models in Pacific Asian patients participating in the CRUCIAL trial. J Korean Med Sci. 2013 Dec;28(12):1741-8. doi: 10.3346/jkms.2013.28.12.1741. Epub 2013 Nov 26.
Hradec J, Zamorano J, Sutradhar S. Post hoc analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial. Curr Med Res Opin. 2013 Jun;29(6):589-96. doi: 10.1185/03007995.2013.783795. Epub 2013 Apr 3.
Kim JH, Zamorano J, Erdine S, Pavia A, Al-Khadra A, Sutradhar S, Yunis C; CR UCIAL Investigators. Proactive cardiovascular risk management versus usual care in patients with and without diabetes mellitus: CRUCIAL trial subanalysis. Postgrad Med. 2012 Jul;124(4):41-53. doi: 10.3810/pgm.2012.07.2565.
Zamorano J, Erdine S, Pavia A, Kim JH, Al-Khadra A, Westergaard M, Sutradhar S, Yunis C; CRUCIAL Investigators. Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial. Curr Med Res Opin. 2011 Apr;27(4):821-33. doi: 10.1185/03007995.2011.555754. Epub 2011 Feb 10.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3841047
Identifier Type: -
Identifier Source: org_study_id
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