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

NCT00407537 | Completed Phase 4 Results

• 1 other identifier: A3841047
• Study Type: interventional
• Target: 1,531
• Locations: 20 countries
• Sites: 125

Brief Summary

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.

Conditions

Hypertension; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12

  Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).

  Baseline, Month 12

Secondary Outcomes (21)

• Framingham 10-year Risk of Total CHD at Month 4

  Baseline, Month 4

• European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12

  Baseline, Month 12

• European SCORE 10-year Risk of Fatal CVD at Month 4

  Baseline, Month 4

• Framingham 10-year Risk of Stroke at Month 12

  Baseline, Month 12

• Framingham 10-year Risk of Stroke at Month 4

  Baseline, Month 4

Study Arms (1)

Caduet

EXPERIMENTAL

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

Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Interventions

Amlodipine besylate/atorvastatin calcium single pill combination 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

Caduet

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (125)

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, 42225, Croatia

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Crikvenica, 51260, Croatia

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Čakovec, 40000, Croatia

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Karlovac, 47000, Croatia

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Rijeka, 51000, Croatia

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Split, 21000, Croatia

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Sveti Križ Začretje, 49223, Croatia

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Špišić-Bukovica, 33404, Croatia

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Varaždin, 42000, Croatia

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Zagreb, 10000, Croatia

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Brno, 656 91, Czechia

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Klatovy, 339 01, Czechia

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Kralupy nad Vltavou, 278 01, Czechia

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Lanškroun, 563 01, Czechia

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Olomouc, 779 00, Czechia

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Pelhřimov, 393 01, Czechia

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Prague, 141 00, Czechia

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Prague, 186 00, Czechia

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Průhonice, 252 43, Czechia

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Ústí nad Labem, 400 07, Czechia

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Vratimov, 739 32, Czechia

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Zlín, 763 02, Czechia

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San Cristóbal, Dominican Republic

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Santo Domingo, 4966, Dominican Republic

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Santo Domingo, Dominican Republic

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Cilandak, Jakarta Selatan, 12430, Indonesia

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Bandung, 40161, Indonesia

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Jakarta, 10430, Indonesia

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Jakarta, 11420, Indonesia

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Semarang, 50231, Indonesia

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Surabaya, 60286, Indonesia

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Tangerang, 15224, Indonesia

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Tanggerang, 15811, Indonesia

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Amman, 11181, Jordan

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Amman, 11942, Jordan

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Irbid, 22110, Jordan

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Kuwait City, Kuwait

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Sasat, 13110, Kuwait

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Beirut, Lebanon

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Byblos, Lebanon

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Kuala Pilah, Negeri Sembilan, 72000, Malaysia

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Seremban, Negeri Sembilan, 70300, Malaysia

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Batu Caves, Selangor, 68100, Malaysia

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Petaling Jaya, Selangor, 47301, Malaysia

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Butterworth, 13000, Malaysia

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Kuala Lumpur, 57000, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Guadalajara, Jalisco, 44200, Mexico

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Guadalajara, Jalisco, 44340, Mexico

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Mexico City, Mexico City, 02720, Mexico

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Mexico City, Mexico City, 07300, Mexico

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Mexico City, Mexico City, 09220, Mexico

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Mexico City, Mexico City, 10700, Mexico

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Toluca, State of Mexico, 50010, Mexico

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Durango, 34078, Mexico

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San Luis Potosí City, 78200, 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, 1218, Philippines

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Manila, 1000, Philippines

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Marikina City, Philippines

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Quezon City, 1101, Philippines

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Moscow, 101953, Russia

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Moscow, 1117292, Russia

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Moscow, 115093, Russia

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Moscow, 117485, Russia

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Saint Petersburg, 190000, Russia

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Saint Petersburg, 192242, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 196084, Russia

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Saint Petersburg, 199106, Russia

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Smolensk, 214018, Russia

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Volgograd, 400008, Russia

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Voronezh, 394053, Russia

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Riyadh, Riyadh 11426, Saudi Arabia

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Wŏnju, Gangwon-do, 220-701, South Korea

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Seongnam-si, Gyeonggi-do, 463-707, South Korea

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Busan, 602-715, South Korea

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Busan, 614-735, South Korea

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Daegu, 700-712, South Korea

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Daegu, 705-718, South Korea

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Daejeon, 301-721, South Korea

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Gwangju, South Korea

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Incheon, 405-760, South Korea

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Seoul, 110-744, South Korea

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Seoul, 135-710, South Korea

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Seoul, 135-720, South Korea

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Seoul, 136-705, South Korea

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Seoul, 137-040, South Korea

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Seoul, 138-736, South Korea

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Seoul, 150-713, South Korea

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Seoul, 152-703, South Korea

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Seoul, South Korea

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Suwon, 443-721, South Korea

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Kaohsiung City, 807, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 402, Taiwan

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Taichung, 407, Taiwan

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Tainan, 704, Taiwan

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Tainan, 710, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taipei, 231, Taiwan

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Rajthevee, Bangkok, 10400, Thailand

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Saimai, Bangkok, 10220, Thailand

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Bangkok, 10330, Thailand

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Ankara, 06100, Turkey (Türkiye)

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Ankara, 06600, Turkey (Türkiye)

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Istanbul, 34087, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Istanbul, 34296, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Izmir, 35340, Turkey (Türkiye)

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Izmir, 35360, 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, 2001, Venezuela

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Valencia, Carabobo, 2001, Venezuela

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Caracas, Dtto Capital/Municipio Libertador, 1050, Venezuela

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Caracas, Dtto Capital/Municipio Libertador, 1053, Venezuela

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Related Publications (4)

• 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.

  PMID: 24339703 DERIVED

• 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.

  PMID: 23464930 DERIVED

• 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.

  PMID: 22913893 DERIVED

• 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.

  PMID: 21306285 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypertension; Hypercholesterolemia

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 28, 2021
• Results First Posted: November 11, 2011

Record last verified: 2021-01

Locations

PA (1); RU (13); KR (19); VE (4); CR (10); CZ (12); SA (1); ID (8); CO (3); MY (7); TU (8); AE (3); LE (2); JO (3); TW (9); DO (3); ME (9); PH (5); KU (2); TH (3)