Trial Outcomes & Findings for Compliance With Treatment For Patients With Hyperlipidemia (NCT NCT00828945)
NCT ID: NCT00828945
Last Updated: 2021-02-21
Results Overview
Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.
COMPLETED
259 participants
Month 12
2021-02-21
Participant Flow
A total of 259 participants were enrolled in the study, out of which 2 participants were not evaluated due to screening failure.
Participant milestones
| Measure |
Statins
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Overall Study
STARTED
|
257
|
|
Overall Study
COMPLETED
|
216
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Statins
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Participant was missing
|
1
|
|
Overall Study
Other
|
36
|
Baseline Characteristics
Compliance With Treatment For Patients With Hyperlipidemia
Baseline characteristics by cohort
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=99 Participants
|
|
Positive response on self -estimated treatment compliance
|
94.2 Percentage of participants
n=99 Participants
|
|
Low-density lipoprotein (LDL) lower than 2.5 millimole/liter (mmol/L)
|
30.7 Percentage of participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria.
Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12
|
36.2 Percentage of participants
Interval 30.3 to 42.4
|
PRIMARY outcome
Timeframe: Month 12Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?".
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12
|
54.9 Percentage of participants
Interval 48.6 to 61.1
|
PRIMARY outcome
Timeframe: Week 8Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8
|
74.3 Percentage of participants
Interval 68.5 to 79.6
|
PRIMARY outcome
Timeframe: Month 6Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6
|
61.1 Percentage of participants
Interval 54.8 to 67.1
|
PRIMARY outcome
Timeframe: Month 12Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12
|
75.9 Percentage of participants
Interval 70.2 to 81.0
|
PRIMARY outcome
Timeframe: Week 8Population: The FAS included all enrolled participants who met all inclusion criteria.
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8
|
9.3 Percentage of participants
Interval 6.1 to 13.6
|
PRIMARY outcome
Timeframe: Month 6Population: The FAS included all enrolled participants who met all inclusion criteria.
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6
|
8.2 Percentage of participants
Interval 5.1 to 12.2
|
PRIMARY outcome
Timeframe: Month 12Population: The FAS included all enrolled participants who met all inclusion criteria.
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12
|
51.4 Percentage of participants
Interval 47.8 to 60.3
|
PRIMARY outcome
Timeframe: Week 8Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8
Yes
|
14.8 Percentage of participants
|
|
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8
No
|
18.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 6Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6
Yes
|
14.0 Percentage of participants
|
|
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6
No
|
10.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 12Population: The FAS included all enrolled participants who met all inclusion criteria.
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Outcome measures
| Measure |
Statins
n=257 Participants
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12
Yes
|
31.9 Percentage of participants
|
|
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12
No
|
13.6 Percentage of participants
|
Adverse Events
Statins
Serious adverse events
| Measure |
Statins
n=259 participants at risk
Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Worsening of angina pectoris
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Death
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.39%
1/259
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER