Hypercholesterolemia, Hypertension
Conditions
Brief summary
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
Interventions
DRUGAmlodipine 2.5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
DRUGAmlodipine 2.5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
DRUGAmlodipine 5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
DRUGAmlodipine 5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female \>=20 to \<80 years of age at Visit 1. * The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP \>=140 mmHg and \<180 mmHg, * LDL-C \>=140 mg/dL and \<250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
Exclusion criteria
* Subjects who had experienced the following coronary artery disease within the past 3 months. * Myocardial infarction * Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting) * Any clinically meaningful valvular disease * Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | 8 weeks | Value at Week 8 minus value at baseline |
| Percent Change in Low Density Lipoprotein-Cholesterol | 8 weeks | Percent of value at Week 8 minus value at baseline over value at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | 2 weeks, 4 weeks , and 8 weeks | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline |
| Percent Change in Total Cholesterol From Baseline to Each Observation Point | 2 weeks, 4 weeks , and 8 weeks | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline |
| Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | 2 weeks, 4 weeks , and 8 weeks | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline |
| Change in Systolic Blood Pressure From Baseline to Each Observation Point | 2 weeks, 4 weeks, and 8 weeks | Value at Week 2, Week 4, or Week 8 minus value at baseline |
| Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | 2 weeks, 4 weeks, and 8 weeks | Value at Week 2, Week 4, or Week 8 minus value at baseline |
| Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | 2 weeks, 4 weeks , and 8 weeks | Value at Week 2, Week 4, or Week 8 minus value at baseline |
| Change in Apolipoprotein B From Baseline to Each Observation Point | 2 weeks, 4 weeks, and 8 weeks | Value at Week 2, Week 4, or Week 8 minus value at baseline |
| Percent Change in Triglycerides From Baseline to Each Observation Point | 2 weeks, 4 weeks , and 8 weeks | Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline |
| Change in Diastolic Blood Pressure From Baseline to Each Observation Point | 2 weeks, 4 weeks , and 8 weeks | Value at Week 2, Week 4, or Week 8 minus value at baseline |
Countries
Japan
Participant flow
Recruitment details
Twenty (20) centers in Japan
Pre-assignment details
A total of 301 subjects entered the 6-week diet observation period and the end of diet observation period, 165 subjects who met all the inclusion criteria for the treatment period and had no conflict to exclusion criteria were randomized to 4 CI-1038 groups.
Participants by arm
| Arm | Count |
|---|---|
| CI-1038 2.5 mg/5 mg Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg) | 43 |
| CI-1038 2.5 mg/10 mg Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg) | 41 |
| CI-1038 5 mg/5 mg Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg) | 41 |
| CI-1038 5 mg/10 mg Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg) | 40 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 1 | 1 |
| Overall Study | Noncompliance | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | CI-1038 2.5 mg/5 mg | CI-1038 2.5 mg/10 mg | CI-1038 5 mg/5 mg | CI-1038 5 mg/10 mg | Total |
|---|---|---|---|---|---|
| Age, Customized 20 to 44 years | 8 participants | 3 participants | 4 participants | 5 participants | 20 participants |
| Age, Customized <20 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized 45 to 64 years | 20 participants | 21 participants | 23 participants | 23 participants | 87 participants |
| Age, Customized >=65 years | 15 participants | 17 participants | 14 participants | 12 participants | 58 participants |
| Region of Enrollment Japan | 43 participants | 41 participants | 41 participants | 40 participants | 165 participants |
| Sex: Female, Male Female | 23 Participants | 28 Participants | 25 Participants | 22 Participants | 98 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 16 Participants | 18 Participants | 67 Participants |
Adverse events
| Event type | EG000 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 | 6 / 43 | 7 / 41 | 8 / 41 | 8 / 40 |
| serious Total, serious adverse events | 0 / 43 | 0 / 41 | 0 / 41 | 0 / 40 |
Outcome results
Primary
Change in Systolic Blood Pressure
Value at Week 8 minus value at baseline
Time frame: 8 weeks
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Change in Systolic Blood Pressure | -16.6 mm Hg | Standard Error 1.65 |
| CI-1038 2.5 mg/10 mg | Change in Systolic Blood Pressure | -15.9 mm Hg | Standard Error 1.69 |
| CI-1038 5 mg/5 mg | Change in Systolic Blood Pressure | -21.8 mm Hg | Standard Error 1.69 |
| CI-1038 5 mg/10 mg | Change in Systolic Blood Pressure | -18.9 mm Hg | Standard Error 1.71 |
Primary
Percent Change in Low Density Lipoprotein-Cholesterol
Percent of value at Week 8 minus value at baseline over value at baseline
Time frame: 8 weeks
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol | -37.2 Percent Change | Standard Error 1.49 |
| CI-1038 2.5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol | -42.5 Percent Change | Standard Error 1.52 |
| CI-1038 5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol | -34.3 Percent Change | Standard Error 1.52 |
| CI-1038 5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol | -40.6 Percent Change | Standard Error 1.54 |
Secondary
Change in Apolipoprotein B From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time frame: 2 weeks, 4 weeks, and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 8 | -40.2 mg/dL | Standard Deviation 9.65 |
| CI-1038 2.5 mg/5 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 2 | -36.6 mg/dL | Standard Deviation 12.55 |
| CI-1038 2.5 mg/5 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 4 | -40.1 mg/dL | Standard Deviation 10.94 |
| CI-1038 2.5 mg/10 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 2 | -45.8 mg/dL | Standard Deviation 12.11 |
| CI-1038 2.5 mg/10 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 8 | -46.4 mg/dL | Standard Deviation 10.87 |
| CI-1038 2.5 mg/10 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 4 | -47.2 mg/dL | Standard Deviation 10.2 |
| CI-1038 5 mg/5 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 2 | -33.5 mg/dL | Standard Deviation 9.86 |
| CI-1038 5 mg/5 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 8 | -36.6 mg/dL | Standard Deviation 12.27 |
| CI-1038 5 mg/5 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 4 | -36.6 mg/dL | Standard Deviation 11.36 |
| CI-1038 5 mg/10 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 2 | -44.4 mg/dL | Standard Deviation 15.46 |
| CI-1038 5 mg/10 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 4 | -45.8 mg/dL | Standard Deviation 13.79 |
| CI-1038 5 mg/10 mg | Change in Apolipoprotein B From Baseline to Each Observation Point | Week 8 | -45.1 mg/dL | Standard Deviation 14.39 |
Secondary
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time frame: 2 weeks, 4 weeks , and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -4.9 mm Hg | Standard Deviation 6.23 |
| CI-1038 2.5 mg/5 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -7.7 mm Hg | Standard Deviation 6.34 |
| CI-1038 2.5 mg/5 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -5.3 mm Hg | Standard Deviation 4.96 |
| CI-1038 2.5 mg/10 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -6.0 mm Hg | Standard Deviation 6.05 |
| CI-1038 2.5 mg/10 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -8.7 mm Hg | Standard Deviation 8.06 |
| CI-1038 2.5 mg/10 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -8.2 mm Hg | Standard Deviation 7.13 |
| CI-1038 5 mg/5 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -9.4 mm Hg | Standard Deviation 6.19 |
| CI-1038 5 mg/5 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -8.1 mm Hg | Standard Deviation 6.24 |
| CI-1038 5 mg/5 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -12.0 mm Hg | Standard Deviation 6.31 |
| CI-1038 5 mg/10 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -8.2 mm Hg | Standard Deviation 6.38 |
| CI-1038 5 mg/10 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -9.9 mm Hg | Standard Deviation 6.57 |
| CI-1038 5 mg/10 mg | Change in Diastolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -9.2 mm Hg | Standard Deviation 6.62 |
Secondary
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time frame: 2 weeks, 4 weeks, and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.2 Ratio | Standard Deviation 0.58 |
| CI-1038 2.5 mg/5 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.2 Ratio | Standard Deviation 0.37 |
| CI-1038 2.5 mg/5 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.3 Ratio | Standard Deviation 0.41 |
| CI-1038 2.5 mg/10 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.4 Ratio | Standard Deviation 0.44 |
| CI-1038 2.5 mg/10 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.4 Ratio | Standard Deviation 0.42 |
| CI-1038 2.5 mg/10 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.4 Ratio | Standard Deviation 0.42 |
| CI-1038 5 mg/5 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.2 Ratio | Standard Deviation 0.52 |
| CI-1038 5 mg/5 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.2 Ratio | Standard Deviation 0.56 |
| CI-1038 5 mg/5 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.1 Ratio | Standard Deviation 0.49 |
| CI-1038 5 mg/10 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.3 Ratio | Standard Deviation 0.53 |
| CI-1038 5 mg/10 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.4 Ratio | Standard Deviation 0.52 |
| CI-1038 5 mg/10 mg | Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.4 Ratio | Standard Deviation 0.49 |
Secondary
Change in Systolic Blood Pressure From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time frame: 2 weeks, 4 weeks, and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -14.2 mm Hg | Standard Deviation 10.26 |
| CI-1038 2.5 mg/5 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -12.8 mm Hg | Standard Deviation 9.63 |
| CI-1038 2.5 mg/5 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -16.8 mm Hg | Standard Deviation 11.4 |
| CI-1038 2.5 mg/10 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -15.3 mm Hg | Standard Deviation 11.59 |
| CI-1038 2.5 mg/10 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -14.6 mm Hg | Standard Deviation 12.33 |
| CI-1038 2.5 mg/10 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -13.5 mm Hg | Standard Deviation 10.18 |
| CI-1038 5 mg/5 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -19.2 mm Hg | Standard Deviation 10.53 |
| CI-1038 5 mg/5 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -20.2 mm Hg | Standard Deviation 11.08 |
| CI-1038 5 mg/5 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -21.3 mm Hg | Standard Deviation 10.07 |
| CI-1038 5 mg/10 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 2 | -16.0 mm Hg | Standard Deviation 9.01 |
| CI-1038 5 mg/10 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 8 | -18.7 mm Hg | Standard Deviation 11.24 |
| CI-1038 5 mg/10 mg | Change in Systolic Blood Pressure From Baseline to Each Observation Point | Week 4 | -19.6 mm Hg | Standard Deviation 11.03 |
Secondary
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time frame: 2 weeks, 4 weeks , and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.3 Ratio | Standard Deviation 0.71 |
| CI-1038 2.5 mg/5 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.4 Ratio | Standard Deviation 0.48 |
| CI-1038 2.5 mg/5 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.3 Ratio | Standard Deviation 0.43 |
| CI-1038 2.5 mg/10 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.6 Ratio | Standard Deviation 0.49 |
| CI-1038 2.5 mg/10 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.6 Ratio | Standard Deviation 0.49 |
| CI-1038 2.5 mg/10 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.5 Ratio | Standard Deviation 0.51 |
| CI-1038 5 mg/5 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.4 Ratio | Standard Deviation 0.65 |
| CI-1038 5 mg/5 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.2 Ratio | Standard Deviation 0.61 |
| CI-1038 5 mg/5 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.4 Ratio | Standard Deviation 0.69 |
| CI-1038 5 mg/10 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 2 | -1.5 Ratio | Standard Deviation 0.64 |
| CI-1038 5 mg/10 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 4 | -1.6 Ratio | Standard Deviation 0.59 |
| CI-1038 5 mg/10 mg | Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point | Week 8 | -1.5 Ratio | Standard Deviation 0.62 |
Secondary
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline
Time frame: 2 weeks, 4 weeks , and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | 7.2 Percent Change | Standard Deviation 10.86 |
| CI-1038 2.5 mg/5 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | 7.2 Percent Change | Standard Deviation 8.16 |
| CI-1038 2.5 mg/5 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | 7.7 Percent Change | Standard Deviation 12.11 |
| CI-1038 2.5 mg/10 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | 7.5 Percent Change | Standard Deviation 13.27 |
| CI-1038 2.5 mg/10 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | 8.3 Percent Change | Standard Deviation 10.7 |
| CI-1038 2.5 mg/10 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | 7.9 Percent Change | Standard Deviation 13.03 |
| CI-1038 5 mg/5 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | 6.6 Percent Change | Standard Deviation 9.12 |
| CI-1038 5 mg/5 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | 9.3 Percent Change | Standard Deviation 13.24 |
| CI-1038 5 mg/5 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | 9.7 Percent Change | Standard Deviation 10.59 |
| CI-1038 5 mg/10 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | 9.9 Percent Change | Standard Deviation 10.32 |
| CI-1038 5 mg/10 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | 10.8 Percent Change | Standard Deviation 9.66 |
| CI-1038 5 mg/10 mg | Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | 11.9 Percent Change | Standard Deviation 13.28 |
Secondary
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline
Time frame: 2 weeks, 4 weeks , and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | -37.6 Percent Change | Standard Deviation 7.8 |
| CI-1038 2.5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | -37.4 Percent Change | Standard Deviation 7.67 |
| CI-1038 2.5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | -34.8 Percent Change | Standard Deviation 9.11 |
| CI-1038 2.5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | -42.9 Percent Change | Standard Deviation 10.28 |
| CI-1038 2.5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | -42.5 Percent Change | Standard Deviation 11 |
| CI-1038 2.5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | -43.8 Percent Change | Standard Deviation 9.3 |
| CI-1038 5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | -32.8 Percent Change | Standard Deviation 9.15 |
| CI-1038 5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | -35.0 Percent Change | Standard Deviation 9.19 |
| CI-1038 5 mg/5 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | -34.2 Percent Change | Standard Deviation 9.22 |
| CI-1038 5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 8 | -40.8 Percent Change | Standard Deviation 11.28 |
| CI-1038 5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 4 | -41.8 Percent Change | Standard Deviation 9.53 |
| CI-1038 5 mg/10 mg | Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point | Week 2 | -40.2 Percent Change | Standard Deviation 13.52 |
Secondary
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline
Time frame: 2 weeks, 4 weeks , and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 4 | -26.6 Percent Change | Standard Deviation 6.36 |
| CI-1038 2.5 mg/5 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 2 | -24.2 Percent Change | Standard Deviation 6.86 |
| CI-1038 2.5 mg/5 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 8 | -26.1 Percent Change | Standard Deviation 6.01 |
| CI-1038 2.5 mg/10 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 4 | -31.5 Percent Change | Standard Deviation 7.08 |
| CI-1038 2.5 mg/10 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 8 | -30.0 Percent Change | Standard Deviation 8.43 |
| CI-1038 2.5 mg/10 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 2 | -30.5 Percent Change | Standard Deviation 8.44 |
| CI-1038 5 mg/5 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 4 | -24.7 Percent Change | Standard Deviation 7.64 |
| CI-1038 5 mg/5 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 8 | -23.4 Percent Change | Standard Deviation 7.78 |
| CI-1038 5 mg/5 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 2 | -23.0 Percent Change | Standard Deviation 7.22 |
| CI-1038 5 mg/10 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 8 | -28.2 Percent Change | Standard Deviation 8.73 |
| CI-1038 5 mg/10 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 2 | -28.3 Percent Change | Standard Deviation 10.04 |
| CI-1038 5 mg/10 mg | Percent Change in Total Cholesterol From Baseline to Each Observation Point | Week 4 | -28.6 Percent Change | Standard Deviation 7.44 |
Secondary
Percent Change in Triglycerides From Baseline to Each Observation Point
Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline
Time frame: 2 weeks, 4 weeks , and 8 weeks
Population: Full Analysis Set, Observed Cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI-1038 2.5 mg/5 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 2 | -15.1 Percent Change | Standard Deviation 33.82 |
| CI-1038 2.5 mg/5 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 8 | -14.1 Percent Change | Standard Deviation 19.72 |
| CI-1038 2.5 mg/5 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 4 | -14.2 Percent Change | Standard Deviation 25.31 |
| CI-1038 2.5 mg/10 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 2 | -27.4 Percent Change | Standard Deviation 22.48 |
| CI-1038 2.5 mg/10 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 8 | -21.1 Percent Change | Standard Deviation 21.68 |
| CI-1038 2.5 mg/10 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 4 | -25.7 Percent Change | Standard Deviation 18.15 |
| CI-1038 5 mg/5 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 4 | -15.1 Percent Change | Standard Deviation 22.42 |
| CI-1038 5 mg/5 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 2 | -16.2 Percent Change | Standard Deviation 20 |
| CI-1038 5 mg/5 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 8 | -10.8 Percent Change | Standard Deviation 31.42 |
| CI-1038 5 mg/10 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 2 | -23.9 Percent Change | Standard Deviation 24.51 |
| CI-1038 5 mg/10 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 8 | -24.0 Percent Change | Standard Deviation 25.15 |
| CI-1038 5 mg/10 mg | Percent Change in Triglycerides From Baseline to Each Observation Point | Week 4 | -23.2 Percent Change | Standard Deviation 28.55 |