CClinicalTrials.gg
CompletedNCT01078285Updated Feb 18, 2021

Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor

An observational study in Medication Non-Adherence, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
21 Years and older
Sex
All
01

Study summary

Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.

02

Conditions studied

  • Medication Non-Adherence

Keywords

  • Integrated program on adherence using counseling
  • support services including cost-sharing where appropriate and educational materials mailed monthly.
03

In context

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Male and female aged >21 years
  • Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
  • Signed informed consent

Inclusion criteria

  • Male and female aged >21 years
  • Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Unwilling to give written informed consent
  • Failed statin treatment in the past
  • Switched from another statin to atorvastatin because of co-pay program
  • Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)

Groups and cohorts

  • Control

    Behavioral: No Patient Counseling

  • Intervention Arm

    Behavioral: Adherence Counseling

Interventions

  • BehavioralNo Patient Counseling

    Patients do not receive any adherence counseling, or other patient support services

  • BehavioralAdherence Counseling

    Patients receive 3-5 minutes of adherence counseling, and other patient support services

06

What researchers measure

Primary outcomes

  1. Proportion of Days Covered (PDC)

    Time frame: 180 days

Secondary outcomes

  1. Medication Possession Ratio (MPR)

    Time frame: 180 days

  2. Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days).

    Time frame: 180 days

  3. Percent of patients that are at least 80% adherent (PDC>0.8)

    Time frame: 180 days

  4. Percent of patients who fill at least one atorvastatin prescription during the period of study

    Time frame: 180 days

07

Study locations

3 sites
  • Prairie Heart Institute
    Springfield, Illinois 62701, United States
  • Memorial Medical Center
    Springfield, Illinois 62702, United States
  • Prairie Diagnostic Center
    Springfield, Illinois 62702, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01078285
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Mar 2, 2010
Start date
Mar 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Feb 18, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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