Clinical trial NCT00407537: Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
Official title: A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 1531
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Framingham 10-year Risk of Total CHD at Month 4
timeFrame: Baseline, Month 4
measure: European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
timeFrame: Baseline, Month 12
measure: European SCORE 10-year Risk of Fatal CVD at Month 4
timeFrame: Baseline, Month 4
measure: Framingham 10-year Risk of Stroke at Month 12
timeFrame: Baseline, Month 12
measure: Framingham 10-year Risk of Stroke at Month 4
timeFrame: Baseline, Month 4
measure: Change From Baseline in Framingham 10-year Risk of Developing Total CHD
timeFrame: Baseline, Month 4, Month 12
measure: Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
timeFrame: Baseline, Month 4, Month 12
measure: Mean Systolic and Diastolic Blood Pressure at Month 4
timeFrame: Month 4
measure: Mean Systolic and Diastolic Blood Pressure at Month 12
timeFrame: Month 12
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
timeFrame: Baseline, Month 4
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
timeFrame: Baseline, Month 4
measure: Change From Baseline in SBP at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in DBP at Month 12
timeFrame: Baseline, Month 12
measure: Mean Lipid Parameters at Month 4
timeFrame: Month 4
measure: Mean Lipid Parameters at Month 12
timeFrame: Month 12
measure: Change From Baseline in Lipid Parameters at Month 4
timeFrame: Baseline, Month 4
measure: Change From Baseline in Lipid Parameters at Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
timeFrame: Month 4, Month 12
measure: Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
timeFrame: Month 4, Month 12
measure: Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
timeFrame: Month 4, Month 12
measure: Number of Participants With Increase of Treatment Dosages After 4 Months.
timeFrame: Month 4
Other outcomes:
Locations:
city: Desamparados
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Heredia
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Breznicki Hum
country: Croatia
facility: Pfizer Investigational Site
city: Cakovec
country: Croatia
facility: Pfizer Investigational Site
city: Crikvenica
country: Croatia
facility: Pfizer Investigational Site
city: Karlovac
country: Croatia
facility: Pfizer Investigational Site
city: Rijeka
country: Croatia
facility: Pfizer Investigational Site
city: Spisic Bukovica
country: Croatia
facility: Pfizer Investigational Site
city: Split
country: Croatia
facility: Pfizer Investigational Site
city: Sv. Kriz Zacretje
country: Croatia
facility: Pfizer Investigational Site
city: Varazdin
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Klatovy
country: Czechia
facility: Pfizer Investigational Site
city: Kralupy nad Vltavou
country: Czechia
facility: Pfizer Investigational Site
city: Lanskroun
country: Czechia
facility: Pfizer Investigational Site
city: Olomouc
country: Czechia
facility: Pfizer Investigational Site
city: Pelhrimov
country: Czechia
facility: Pfizer Investigational Site
city: Praha 4
country: Czechia
facility: Pfizer Investigational Site
city: Praha 8
country: Czechia
facility: Pfizer Investigational Site
city: Pruhonice
country: Czechia
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czechia
facility: Pfizer Investigational Site
city: Vratimov
country: Czechia
facility: Pfizer Investigational Site
city: Zlin 4
country: Czechia
facility: Pfizer Investigational Site
city: San Cristobal
country: Dominican Republic
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
city: Cilandak
country: Indonesia
facility: Pfizer Investigational Site
state: Jakarta Selatan
city: Bandung
country: Indonesia
facility: Pfizer Investigational Site
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
city: Semarang
country: Indonesia
facility: Pfizer Investigational Site
city: Surabaya
country: Indonesia
facility: Pfizer Investigational Site
city: Tangerang
country: Indonesia
facility: Pfizer Investigational Site
city: Tanggerang
country: Indonesia
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Irbid
country: Jordan
facility: Pfizer Investigational Site
city: Wonju-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gangwon-Do
city: Seongnam-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul,
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Suwon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Kuwait
country: Kuwait
facility: Pfizer Investigational Site
city: Sasat
country: Kuwait
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Jbeil
country: Lebanon
facility: Pfizer Investigational Site
city: Kuala Pilah
country: Malaysia
facility: Pfizer Investigational Site
state: Negeri Sembilan
city: Seremban
country: Malaysia
facility: Pfizer Investigational Site
state: Negeri Sembilan
city: Batu Caves
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Butterworth
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Toluca
country: Mexico
facility: Pfizer Investigational Site
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Durango
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Panama City
country: Panama
facility: Pfizer Investigational Site
city: Panama
country: Panama
facility: Pfizer Investigational Site
city: San Juan
country: Philippines
facility: Pfizer Investigational Site
state: Metro Manila
city: Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Marikina City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Volgograd
country: Russian Federation
facility: Pfizer Investigational Site
city: Voronezh
country: Russian Federation
facility: Pfizer Investigational Site
city: Riyadh 11426
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Rajthevee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Saimai
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Abu Dhabi
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Al Ain
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Dubai
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Naguanagua/Valencia
country: Venezuela
facility: Pfizer Investigational Site
state: Carabobo
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Dtto Capital/Municipio Libertador
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Dtto Capital/Municipio Libertador
city: Valencia
country: Venezuela
facility: Pfizer Investigational Site
state: Estado Carabobo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.