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Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00124072
First received: July 22, 2005
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: March 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cardiovascular Disease
Interventions: Drug: Simvastatin 20 mg daily
Dietary Supplement: Folic acid 2 mg + vitamin B12 1 mg daily
Drug: Simvastatin 80 mg daily
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient In: 28-SEP-1998, Last Patient Last Visit: 22-May-2008 Eighty-eight (88) sites in 3 countries: England 72, Scotland 12 and Wales 4.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients entered a run-in period during which they received simvastatin 20 mg daily and placebo-vitamin tablets for 2 months. Eligible patients who completed run-in were then randomized in a 2x2 factorial blinded design between simvastatin 80 mg daily versus simvastatin 20 mg daily and folic acid 2 mg + vitamin B12 1 mg daily versus placebo.

Reporting Groups
  Description
Simvastatin 20 mg + Folic Acid and B12 Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
Simvastatin 80 mg + Folic Acid and B12 Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
Simvastatin 20 mg + Placebo Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
Simvastatin 80 mg + Placebo Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily

Participant Flow:   Overall Study
    Simvastatin 20 mg + Folic Acid and B12   Simvastatin 80 mg + Folic Acid and B12   Simvastatin 20 mg + Placebo   Simvastatin 80 mg + Placebo
STARTED   3017   3016   3016   3015 
COMPLETED   2503   2504   2524   2515 
NOT COMPLETED   514   512   492   500 
Lost to Follow-up for Mortality                0                3                2                2 
Lost to Follow-up for Morbidity                15                25                19                18 
Death                499                484                471                480 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Simvastatin 20 mg + Folic Acid and B12 Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
Simvastatin 80 mg + Folic Acid and B12 Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
Simvastatin 20 mg + Placebo Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
Simvastatin 80 mg + Placebo Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
Total Total of all reporting groups

Baseline Measures
   Simvastatin 20 mg + Folic Acid and B12   Simvastatin 80 mg + Folic Acid and B12   Simvastatin 20 mg + Placebo   Simvastatin 80 mg + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 3017   3016   3016   3015   12064 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (8.9)   64.2  (8.9)   64.2  (8.9)   64.2  (8.9)   64.2  (8.9) 
Gender 
[Units: Participants]
         
Female   513   514   513   512   2052 
Male   2504   2502   2503   2503   10012 
Region of Enrollment 
[Units: Participants]
         
United Kingdom   3017   3016   3016   3015   12064 


  Outcome Measures

1.  Primary:   Major Vascular Events (MVE)   [ Time Frame: 6.7 years median follow-up ]

2.  Secondary:   MVEs Separately in Year 1 and in Later Years   [ Time Frame: 6.7 years median follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   MVEs in Patients Subdivided Into 3 Groups by Baseline Low-density Lipoprotein (LDL)   [ Time Frame: 6.7 years median follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   MVEs in Presence and Absence of the Other Factorial Treatment   [ Time Frame: 6.7 years median follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Major Coronary Events   [ Time Frame: 6.7 years median follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Total Strokes   [ Time Frame: 6.7 years median follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: CTSU Reception
Organization: CTSU, University of Oxford
phone: 01865 743743
e-mail: secretary@ctsu.ox.ac.uk



Responsible Party: Professor Rory Collins, University of Oxford
ClinicalTrials.gov Identifier: NCT00124072     History of Changes
Other Study ID Numbers: CTSUSEARCH1
Study First Received: July 22, 2005
Results First Received: March 29, 2010
Last Updated: January 31, 2012