Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors

NCT ID: NCT00407537

Last Updated: 2021-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-10-31

Brief Summary

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To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.

Detailed Description

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Conditions

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Hypertension Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caduet

Open label caduet added to usual care regimen followed by investigators.

Group Type EXPERIMENTAL

Amlodipine besylate/atorvastatin calcium single pill combination

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria

* Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
* Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
Minimum Eligible Age

35 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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Costa Rica Croatia Czechia Dominican Republic Indonesia Jordan Kuwait Lebanon Malaysia Mexico Panama Philippines Russia Saudi Arabia South Korea Taiwan Thailand Turkey (Türkiye) United Arab Emirates Venezuela

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.

Reference Type DERIVED
PMID: 24339703 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23464930 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22913893 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21306285 (View on PubMed)

Related Links

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Other Identifiers

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A3841047

Identifier Type: -

Identifier Source: org_study_id

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