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A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00783263
Enrollment
440
Registered
2008-10-31
Start date
2008-11-30
Completion date
2010-05-31
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Interventions

DRUGComparator: rosuvastatin 5 mg + ezetimibe 10 mg

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.

DRUGComparator: rosuvastatin 10 mg

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.

DRUGComparator: rosuvastatin 10 mg + ezetimibe 10 mg

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.

DRUGComparator: rosuvastatin 20 mg

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive * Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD)) * Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)

Exclusion criteria

* Participant weighs less than 100 lbs (45 kg). * Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications. * If female, participant is pregnant or breastfeeding. * Participant consumes more than 2 alcoholic beverages per day. * Participant has been in a clinical trial within the last 30 days. * Participant has heart problems such as CHF, unstable angina or heart attack. * Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months. * Participant has liver disease. * Participant is Human Immunodeficiency Virus (HIV) positive. * Participant has a history of drug or alcohol abuse in the last year.

Design outcomes

Primary

MeasureTime frameDescription
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of TreatmentBaseline to 6 weeksThe percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Secondary

MeasureTime frameDescription
Number of Participants Who Reached Their Target LDL-C Level6 weeks of treatmentParticipants were analyzed to evaluate the LDL-C (\<100 mg/dL for moderately high risk patients and high risk patients without AVD and \<70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.
Number of Participants in Each Stratum Who Reached Their Target LDL-C Level6 weeks of treatmentParticipants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each StratumBaseline to 6 weeksThe percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl6 weeks of treatmentParticipants in stratum I and in stratum II who reached the LDL-C Level of \<70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).
Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsBaseline to 6 weeksParticipants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.
Number of Participants Who Reached the LDL-C Level of <70 mg/dl6 weeks of treatmentParticipants across all strata who reached the LDL-C Level of \<70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Participant flow

Participants by arm

ArmCount
Rosuvastatin 5 mg + Ezetimibe 10 mg
Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
99
Rosuvastatin 10 mg
Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
98
Rosuvastatin 10 mg + Ezetimibe 10 mg
Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
122
Rosuvastatin 20 mg
Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
121
Total440

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event3021
Overall StudyLost to Follow-up1100
Overall StudyWithdrawal by Subject0112

Baseline characteristics

CharacteristicRosuvastatin 5 mg + Ezetimibe 10 mgRosuvastatin 10 mgRosuvastatin 10 mg + Ezetimibe 10 mgRosuvastatin 20 mgTotal
Age, Customized
< 65 years
63 participants62 participants71 participants71 participants267 participants
Age, Customized
≥ 65 years
36 participants36 participants51 participants50 participants173 participants
Sex: Female, Male
Female
35 Participants40 Participants56 Participants37 Participants168 Participants
Sex: Female, Male
Male
64 Participants58 Participants66 Participants84 Participants272 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 990 / 980 / 1220 / 121
serious
Total, serious adverse events
0 / 991 / 980 / 1221 / 121

Outcome results

Primary

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment

The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Time frame: Baseline to 6 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment-21.57 percent changeStandard Deviation 25.09
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment-5.58 percent changeStandard Deviation 25.42
p-value: <0.00195% CI: [-19.89, -10.6]Longitudinal Data Analysis (LDA)
Secondary

Number of Participants in Each Stratum Who Reached Their Target LDL-C Level

Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.

Time frame: 6 weeks of treatment

ArmMeasureValue (NUMBER)
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgNumber of Participants in Each Stratum Who Reached Their Target LDL-C Level54 participants
Rosuvastatin (10 or 20 mg)Number of Participants in Each Stratum Who Reached Their Target LDL-C Level30 participants
Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)Number of Participants in Each Stratum Who Reached Their Target LDL-C Level76 participants
Rosuvastatin 20 mg (Stratum II)Number of Participants in Each Stratum Who Reached Their Target LDL-C Level37 participants
p-value: <0.00195% CI: [1.7, 5.8]Logistic Regression
p-value: <0.00195% CI: [3.4, 12.3]Logistic Regression
Secondary

Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl

Participants in stratum I and in stratum II who reached the LDL-C Level of \<70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).

Time frame: 6 weeks of treatment

ArmMeasureValue (NUMBER)
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgNumber of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl31 participants
Rosuvastatin (10 or 20 mg)Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl12 participants
Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl65 participants
Rosuvastatin 20 mg (Stratum II)Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl26 participants
Comparison: Stratum Ip-value: <0.00195% CI: [2.2, 11.8]Logistic Regression
Comparison: Stratum IIp-value: <0.00195% CI: [5.2, 24.8]Logistic Regression
Secondary

Number of Participants Who Reached Their Target LDL-C Level

Participants were analyzed to evaluate the LDL-C (\<100 mg/dL for moderately high risk patients and high risk patients without AVD and \<70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.

Time frame: 6 weeks of treatment

ArmMeasureValue (NUMBER)
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgNumber of Participants Who Reached Their Target LDL-C Level130 participants
Rosuvastatin (10 or 20 mg)Number of Participants Who Reached Their Target LDL-C Level67 participants
p-value: <0.00195% CI: [2.9, 6.9]Logistic Regression
Secondary

Number of Participants Who Reached the LDL-C Level of <70 mg/dl

Participants across all strata who reached the LDL-C Level of \<70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Time frame: 6 weeks of treatment

ArmMeasureValue (NUMBER)
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgNumber of Participants Who Reached the LDL-C Level of <70 mg/dl96 participants
Rosuvastatin (10 or 20 mg)Number of Participants Who Reached the LDL-C Level of <70 mg/dl38 participants
p-value: <0.00195% CI: [4.6, 14]Logistic Regression
Secondary

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum

The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Time frame: Baseline to 6 weeks

ArmMeasureValue (MEAN)Dispersion
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum-18.57 percentage changeStandard Deviation 26.35
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum-4.96 percentage changeStandard Deviation 22.42
Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum-24.00 percentage changeStandard Deviation 23.86
Rosuvastatin 20 mg (Stratum II)Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum-6.07 percentage changeStandard Deviation 27.65
p-value: <0.00195% CI: [-18.95, -5.67]Longitudinal Data Analysis (LDA)
p-value: <0.00195% CI: [-23.92, -10.99]Longitudinal Data Analysis (LDA)
Secondary

Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels

Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.

Time frame: Baseline to 6 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsNon High-Density Liproprotein Cholesterol-17.59 percentage changeStandard Deviation 23.55
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsNon-HDL Cholestrol/HDL Cholesterol-14.51 percentage changeStandard Deviation 35.39
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsHigh-Density Lipoprotein Cholesterol-0.67 percentage changeStandard Deviation 15.51
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsApolipoprotein B (Apo B)-14.31 percentage changeStandard Deviation 18.61
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsLDL Cholesterol/HDL Cholesterol-19.48 percentage changeStandard Deviation 27.63
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsApolipoprotein A-I (Apo A-I)-1.44 percentage changeStandard Deviation 12.49
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsTriglycerides-5.96 percentage changeStandard Deviation 36.45
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsApolipoprotein B/Apo A-I-11.98 percentage changeStandard Deviation 20.84
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsTotal Cholesterol/HDL Cholesterol-10.57 percentage changeStandard Deviation 25.87
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levelshs-C-Reactive Protein-13.98 percentage changeStandard Deviation 72.19
Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mgPercent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsTotal Cholesterol (TC)-13.00 percentage changeStandard Deviation 17.51
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levelshs-C-Reactive Protein-12.82 percentage changeStandard Deviation 73.08
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsTotal Cholesterol (TC)-3.76 percentage changeStandard Deviation 14.35
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsTriglycerides-3.60 percentage changeStandard Deviation 32.83
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsHigh-Density Lipoprotein Cholesterol2.18 percentage changeStandard Deviation 13.38
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsNon High-Density Liproprotein Cholesterol-5.29 percentage changeStandard Deviation 21.2
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsLDL Cholesterol/HDL Cholesterol-6.18 percentage changeStandard Deviation 27.82
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsTotal Cholesterol/HDL Cholesterol-4.40 percentage changeStandard Deviation 18.27
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsNon-HDL Cholestrol/HDL Cholesterol-5.31 percentage changeStandard Deviation 26.63
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsApolipoprotein B (Apo B)-4.25 percentage changeStandard Deviation 17.56
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsApolipoprotein A-I (Apo A-I)1.06 percentage changeStandard Deviation 11.56
Rosuvastatin (10 or 20 mg)Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)LevelsApolipoprotein B/Apo A-I-4.11 percentage changeStandard Deviation 19.61
Comparison: Total Cholesterol (mg/dL)p-value: <0.00195% CI: [-11.59, -5.71]Longitudinal Data Analysis
Comparison: Triglycerides (mg/dL)p-value: 0.30695% CI: [-9.04, 2.84]Longitudinal Data Analysis
Comparison: High-Density Lipoprotein Cholesterolp-value: 0.11195% CI: [-4.79, 0.49]Longitudinal Data Analysis
Comparison: Non High-Density Liproprotein Cholesterolp-value: <0.00195% CI: [-16.1, -7.86]Longitudinal Data Analysis
Comparison: LDL Cholesterol/HDL Cholesterolp-value: <0.00195% CI: [-18.36, -8.13]Longitudinal Data Analysis
Comparison: Total Cholesterol/HDL Cholesterolp-value: 0.00295% CI: [-10.53, -2.36]Longitudinal Data Analysis
Comparison: Non-HDL Cholestrol/HDL Cholesterolp-value: 0.00195% CI: [-15.3, -3.75]Longitudinal Data Analysis
Comparison: Apolipoprotein B (Apo B)p-value: <0.00195% CI: [-12.74, -6.08]Longitudinal Data Analysis
Comparison: Apolipoprotein A-I (Apo A-I)p-value: 0.10295% CI: [-3.99, 0.36]Longitudinal Data Analysis
Comparison: Apolipoprotein B/Apo A-Ip-value: <0.00195% CI: [-11.25, -3.83]Longitudinal Data Analysis
Comparison: hs-C-Reactive Proteinp-value: 0.86195% CI: [-13.13, 10.97]Longitudinal Data Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026