HypertensionPhase 4CRUCIALNCT00407537

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

A Phase 4 study testing Amlodipine besylate/atorvastatin calcium single pill combination in people with Hypertension and Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 125 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 35 to 79 years
Conditions the study is for: Hypertension, Hypercholesterolemia
What is being tested?: Amlodipine besylate/atorvastatin calcium single pill combination
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,531 participants
Where: 125 sitesin 20 countries
Study dates: Mar 2007to Oct 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

125 sites in 20 countries.

Country

City, postcode or hospital

125 sites in 20 countries

South Korea19 sites

Pfizer Investigational Site
Busan, 602-715
Pfizer Investigational Site
Busan, 614-735
Pfizer Investigational Site
Daegu, 700-712
Pfizer Investigational Site
Daegu, 705-718
Pfizer Investigational Site
Daejeon, 301-721
Pfizer Investigational Site
Gwangju
Pfizer Investigational Site
Incheon, 405-760
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, 463-707
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 135-720
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 137-040
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 150-713
Pfizer Investigational Site
Seoul, 152-703
Pfizer Investigational Site
Seoul
Pfizer Investigational Site
Suwon, 443-721
Pfizer Investigational Site
Wŏnju, Gangwon-do, 220-701

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Russia13 sites

Pfizer Investigational Site
Moscow, 101953
Pfizer Investigational Site
Moscow, 1117292
Pfizer Investigational Site
Moscow, 115093
Pfizer Investigational Site
Moscow, 117485
Pfizer Investigational Site
Saint Petersburg, 190000
Pfizer Investigational Site
Saint Petersburg, 192242
Pfizer Investigational Site
Saint Petersburg, 194291
Pfizer Investigational Site
Saint Petersburg, 195067
Pfizer Investigational Site
Saint Petersburg, 196084
Pfizer Investigational Site
Saint Petersburg, 199106
Pfizer Investigational Site
Smolensk, 214018
Pfizer Investigational Site
Volgograd, 400008
Pfizer Investigational Site
Voronezh, 394053

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Czechia12 sites

Pfizer Investigational Site
Brno, 656 91
Pfizer Investigational Site
Klatovy, 339 01
Pfizer Investigational Site
Kralupy nad Vltavou, 278 01
Pfizer Investigational Site
Lanškroun, 563 01
Pfizer Investigational Site
Olomouc, 779 00
Pfizer Investigational Site
Pelhřimov, 393 01
Pfizer Investigational Site
Prague, 141 00
Pfizer Investigational Site
Prague, 186 00
Pfizer Investigational Site
Průhonice, 252 43
Pfizer Investigational Site
Ústí nad Labem, 400 07
Pfizer Investigational Site
Vratimov, 739 32
Pfizer Investigational Site
Zlín, 763 02

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Croatia10 sites

Pfizer Investigational Site
Breznički Hum, 42225
Pfizer Investigational Site
Čakovec, 40000
Pfizer Investigational Site
Crikvenica, 51260
Pfizer Investigational Site
Karlovac, 47000
Pfizer Investigational Site
Rijeka, 51000
Pfizer Investigational Site
Špišić-Bukovica, 33404
Pfizer Investigational Site
Split, 21000
Pfizer Investigational Site
Sveti Križ Začretje, 49223
Pfizer Investigational Site
Varaždin, 42000
Pfizer Investigational Site
Zagreb, 10000

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Mexico9 sites

Pfizer Investigational Site
Durango, 34078
Pfizer Investigational Site
Guadalajara, Jalisco, 44200
Pfizer Investigational Site
Guadalajara, Jalisco, 44340
Pfizer Investigational Site
Mexico City, Mexico City, 02720
Pfizer Investigational Site
Mexico City, Mexico City, 07300
Pfizer Investigational Site
Mexico City, Mexico City, 09220
Pfizer Investigational Site
Mexico City, Mexico City, 10700
Pfizer Investigational Site
San Luis Potosí City, 78200
Pfizer Investigational Site
Toluca, State of Mexico, 50010

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Taiwan9 sites

Pfizer Investigational Site
Kaohsiung City, 807
Pfizer Investigational Site
Kaohsiung City, 833
Pfizer Investigational Site
Taichung, 402
Pfizer Investigational Site
Taichung, 407
Pfizer Investigational Site
Tainan, 704
Pfizer Investigational Site
Tainan, 710
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taipei, 231

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Indonesia8 sites

Pfizer Investigational Site
Bandung, 40161
Pfizer Investigational Site
Cilandak, Jakarta Selatan, 12430
Pfizer Investigational Site
Jakarta, 10430
Pfizer Investigational Site
Jakarta, 11420
Pfizer Investigational Site
Semarang, 50231
Pfizer Investigational Site
Surabaya, 60286
Pfizer Investigational Site
Tangerang, 15224
Pfizer Investigational Site
Tanggerang, 15811

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Turkey (Türkiye)8 sites

Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Ankara, 06600
Pfizer Investigational Site
Istanbul, 34087
Pfizer Investigational Site
Istanbul, 34098
Pfizer Investigational Site
Istanbul, 34296
Pfizer Investigational Site
Istanbul, 34390
Pfizer Investigational Site
Izmir, 35340
Pfizer Investigational Site
Izmir, 35360

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Malaysia7 sites

Pfizer Investigational Site
Batu Caves, Selangor, 68100
Pfizer Investigational Site
Butterworth, 13000
Pfizer Investigational Site
Kuala Lumpur, 57000
Pfizer Investigational Site
Kuala Lumpur, 59100
Pfizer Investigational Site
Kuala Pilah, Negeri Sembilan, 72000
Pfizer Investigational Site
Petaling Jaya, Selangor, 47301
Pfizer Investigational Site
Seremban, Negeri Sembilan, 70300

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Philippines5 sites

Pfizer Investigational Site
Makati City, 1218
Pfizer Investigational Site
Manila, 1000
Pfizer Investigational Site
Marikina City
Pfizer Investigational Site
Quezon City, 1101
Pfizer Investigational Site
San Juan City, National Capital Region

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Venezuela4 sites

Pfizer Investigational Site
Caracas, Dtto Capital/Municipio Libertador, 1050
Pfizer Investigational Site
Caracas, Dtto Capital/Municipio Libertador, 1053
Pfizer Investigational Site
Naguanagua/Valencia, Carabobo, 2001
Pfizer Investigational Site
Valencia, Carabobo, 2001

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Costa Rica3 sites

Pfizer Investigational Site
Desamparados, Provincia de San José
Pfizer Investigational Site
Heredia
Pfizer Investigational Site
San José

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Dominican Republic3 sites

Pfizer Investigational Site
San Cristobal
Pfizer Investigational Site
Santo Domingo, 4966
Pfizer Investigational Site
Santo Domingo

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Jordan3 sites

Pfizer Investigational Site
Amman, 11181
Pfizer Investigational Site
Amman, 11942
Pfizer Investigational Site
Irbid, 22110

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Thailand3 sites

Pfizer Investigational Site
Bangkok, 10330
Pfizer Investigational Site
Rajthevee, Bangkok, 10400
Pfizer Investigational Site
Saimai, Bangkok, 10220

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United Arab Emirates3 sites

Pfizer Investigational Site
Abu Dhabi
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Al Ain City
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Dubai

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Kuwait2 sites

Pfizer Investigational Site
Kuwait City
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Sasat, 13110

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Lebanon2 sites

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Beirut
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Byblos

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Panama1 site

Pfizer Investigational Site
Panama City

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Saudi Arabia1 site

Pfizer Investigational Site
Riyadh, Riyadh 11426

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About this study

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

Conditions: Hypertension, Hypercholesterolemia
Being tested: Amlodipine besylate/atorvastatin calcium single pill combination
Medical subject headings: Hypertension, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine besylate/atorvastatin calcium single pill combinationDrug
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

Study groups in NCT00407537
Study group	Role	What they receive
Caduet	Experimental	Open label caduet added to usual care regimen followed by investigators. Receives: Drug: Amlodipine besylate/atorvastatin calcium single pill combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, Month 12

Secondary outcomes (21)

Framingham 10-year Risk of Total CHD at Month 4
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 after 4 months of treatment (Month 4).
Measured: Baseline, Month 4
European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).
Measured: Baseline, Month 12
European SCORE 10-year Risk of Fatal CVD at Month 4
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).
Measured: Baseline, Month 4
Framingham 10-year Risk of Stroke at Month 12
Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Measured: Baseline, Month 12
Framingham 10-year Risk of Stroke at Month 4
Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Measured: Baseline, Month 4
Change From Baseline in Framingham 10-year Risk of Developing Total CHD
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. Change from baseline calculated as mean at observation minus mean at Baseline.
Measured: Baseline, Month 4, Month 12
Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.
Measured: Baseline, Month 4, Month 12
Mean Systolic and Diastolic Blood Pressure at Month 4
Measured: Month 4
Mean Systolic and Diastolic Blood Pressure at Month 12
Measured: Month 12
Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
Measured: Baseline, Month 4
Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
Measured: Baseline, Month 4
Change From Baseline in SBP at Month 12
Measured: Baseline, Month 12
Change From Baseline in DBP at Month 12
Measured: Baseline, Month 12
Mean Lipid Parameters at Month 4
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Measured: Month 4
Mean Lipid Parameters at Month 12
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Measured: Month 12
Change From Baseline in Lipid Parameters at Month 4
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
Measured: Baseline, Month 4
Change From Baseline in Lipid Parameters at Month 12
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Measured: Baseline, Month 12
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.
Measured: Month 4, Month 12
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.
Measured: Month 4, Month 12
Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
Treatments indicative of prescribed medications other than study provided Caduet.
Measured: Month 4, Month 12
Number of Participants With Increase of Treatment Dosages After 4 Months.
Treatments indicative of prescribed medications other than study provided Caduet.
Measured: Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Oct 2009

First posted5 Dec 2006 (estimated)
Study startMar 2007
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,531 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00407537
Sponsor's protocol ID: A3841047
Acronym: CRUCIAL
Status last verified: Jan 2021
First submitted: 1 Dec 2006
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24339703
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.
PubMed 23464930
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.
PubMed 22913893
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.
PubMed 21306285

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00407537
Acronym / sponsor ID: CRUCIAL / A3841047
Conditions: Hypertension, Hypercholesterolemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,531 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 5 Dec 2006 (estimated)
Results: Posted 11 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Caduet	Experimental	Drug: Amlodipine besylate/atorvastatin calcium single pill combinationOpen label caduet added to usual care regimen followed by investigators.

Who may qualify

Ages: 35 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine besylate/atorvastatin calcium single pill combinationOpen 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	Drug	Caduet

Primary outcome

Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
Time frame: Baseline, 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).

21 secondary outcomes

Framingham 10-year Risk of Total CHD at Month 4
Time frame: Baseline, Month 4
European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
Time frame: Baseline, Month 12
European SCORE 10-year Risk of Fatal CVD at Month 4
Time frame: Baseline, Month 4
Framingham 10-year Risk of Stroke at Month 12
Time frame: Baseline, Month 12
Framingham 10-year Risk of Stroke at Month 4
Time frame: Baseline, Month 4
Change From Baseline in Framingham 10-year Risk of Developing Total CHD
Time frame: Baseline, Month 4, Month 12
Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
Time frame: Baseline, Month 4, Month 12
Mean Systolic and Diastolic Blood Pressure at Month 4
Time frame: Month 4
Mean Systolic and Diastolic Blood Pressure at Month 12
Time frame: Month 12
Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
Time frame: Baseline, Month 4
Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
Time frame: Baseline, Month 4
Change From Baseline in SBP at Month 12
Time frame: Baseline, Month 12
Change From Baseline in DBP at Month 12
Time frame: Baseline, Month 12
Mean Lipid Parameters at Month 4
Time frame: Month 4
Mean Lipid Parameters at Month 12
Time frame: Month 12
Change From Baseline in Lipid Parameters at Month 4
Time frame: Baseline, Month 4
Change From Baseline in Lipid Parameters at Month 12
Time frame: Baseline, Month 12
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
Time frame: Month 4, Month 12
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
Time frame: Month 4, Month 12
Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
Time frame: Month 4, Month 12
Number of Participants With Increase of Treatment Dosages After 4 Months.
Time frame: Month 4

Results and safety

Results posted to the registry on 11 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caduet	779	686
Usual Care	682	638

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

Time frame: Baseline, Month 12. Mean (Standard Deviation). Unit: percent risk

Measure	Caduet n = 748	Usual Care n = 655
Value	12.5 (8.26)	16.3 (10.51)

Caduet vs Usual Care: LSMean difference: -4.72 (95% CI -5.55 to -3.89), p <0.001, Mixed-effect linear model

Population analysed: Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.

21 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caduet	51 of 779 (6.5%)	356 of 779 (45.7%)	Not reported
Usual Care	22 of 682 (3.2%)	289 of 682 (42.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24339703Cho 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.
Derived from this study: PubMed 23464930Hradec 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.
Derived from this study: PubMed 22913893Kim 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.
Derived from this study: PubMed 21306285Zamorano 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

125 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in South Korea, Russia, Czechia, Croatia, Mexico and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00407537, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.