Trial Outcomes & Findings for Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications (NCT NCT00993915)
NCT ID: NCT00993915
Last Updated: 2021-02-18
Results Overview
COMPLETED
687 participants
Month 6
2021-02-18
Participant Flow
Participant milestones
| Measure |
Atorvastatin
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
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|---|---|
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Overall Study
STARTED
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687
|
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Overall Study
COMPLETED
|
678
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Atorvastatin
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
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|---|---|
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Overall Study
Insufficient clinical response
|
3
|
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Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other
|
1
|
|
Overall Study
Ongoing
|
3
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Baseline Characteristics
Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=687 Participants
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
|
|---|---|
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Age, Customized
Between 18 and 44 years
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35 participants
n=99 Participants
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Age, Customized
Between 45 and 64 years
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493 participants
n=99 Participants
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Age, Customized
Greater than or equal to (≥) 65 years
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159 participants
n=99 Participants
|
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Sex: Female, Male
Female
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283 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
404 Participants
n=99 Participants
|
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Total cholesterol
|
271.69 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 61.99 • n=99 Participants
|
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Low-density lipoprotein (LDL) cholesterol
|
179.09 mg/dL
STANDARD_DEVIATION 54.19 • n=99 Participants
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High-density lipoprotein (HDL) cholesterol
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48.37 mg/dL
STANDARD_DEVIATION 20.14 • n=99 Participants
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Triglycerides
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207.56 mg/dL
STANDARD_DEVIATION 145.61 • n=99 Participants
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PRIMARY outcome
Timeframe: Month 6Population: Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.
Outcome measures
| Measure |
Atorvastatin
n=592 Participants
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
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|---|---|
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Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit
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51.52 percentage of participants
Interval 47.5 to 55.52
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SECONDARY outcome
Timeframe: Month 1Population: Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6Population: FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.
Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline
Outcome measures
| Measure |
Atorvastatin
n=593 Participants
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
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|---|---|
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Change From Baseline in Lipid Parameters
Change at Month 6 in Total cholesterol, n=593
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-98.06 mg/dL
Interval -102.58 to -93.53
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Change From Baseline in Lipid Parameters
Change at Month 6 in LDL, n=583
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-76.84 mg/dL
Interval -80.49 to -73.19
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Change From Baseline in Lipid Parameters
Change at Month 6 in HDL, n=562
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3.15 mg/dL
Interval 1.61 to 4.7
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Change From Baseline in Lipid Parameters
Change at Month 6 in Triglycerides, n=585
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-70.57 mg/dL
Interval -80.73 to -60.41
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SECONDARY outcome
Timeframe: Month 6Population: FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.
Percent change from baseline calculated as: 100\*(change at Month X)/(baseline value).
Outcome measures
| Measure |
Atorvastatin
n=593 Participants
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
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|---|---|
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Percent Change From Baseline in Lipid Parameters
Change at Month 6 in Total cholesterol, n=593
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-33.57 percent change
Interval -36.11 to -31.03
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Percent Change From Baseline in Lipid Parameters
Change at Month 6 in LDL, n=583
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-40.66 percent change
Interval -42.15 to -39.17
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Percent Change From Baseline in Lipid Parameters
Change at Month 6 in HDL, n=562
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14.49 percent change
Interval 11.38 to 17.6
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Percent Change From Baseline in Lipid Parameters
Change at Month 6 in Triglyceride, n=585
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-23.05 percent change
Interval -25.58 to -20.51
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OTHER_PRE_SPECIFIED outcome
Timeframe: Month 1Population: Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.
Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 1Population: Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.
Percent change from baseline calculated as: 100\*(change at Month X)/(baseline value).
Outcome measures
Outcome data not reported
Adverse Events
Atorvastatin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin
n=687 participants at risk
The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
|
0.15%
1/687
|
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Gastrointestinal disorders
Gastritis
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0.15%
1/687
|
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General disorders
Asthenia
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0.15%
1/687
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Infections and infestations
Herpes zoster
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0.15%
1/687
|
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Musculoskeletal and connective tissue disorders
Arthralgia
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0.15%
1/687
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Nervous system disorders
Cerebrovascular disorder
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0.15%
1/687
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Nervous system disorders
Dizziness
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0.15%
1/687
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Respiratory, thoracic and mediastinal disorders
Respiratory disorder
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0.15%
1/687
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Vascular disorders
Hypertension
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0.15%
1/687
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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