Angina Pectoris, Hypercholesterolemia, Hypertension
Conditions
Brief summary
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.
Interventions
DRUGCaduet
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3): * (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value \< 140/90mmHg at Week 0) * (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2 * (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C \< 250 mg/dL, and TG \< 400 mg/dL at Week -2 * Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3): * (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value \< 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris * (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2 * (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C \< 250 mg/dL, and TG \< 400 mg/dL at Week -2
Exclusion criteria
* Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure \< 140mmHg and diastolic blood pressure \< 90 mmHg. * Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 52 weeks | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Value at each visits minus value at baseline |
| Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Value at each visits minus value at baseline |
| Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Value at each visits minus value at baseline |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Weeks 4, 12, 24, and 52 | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 |
| Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Weeks 4, 12, 24, and 52 | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 |
| Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Value at each visits minus value at baseline |
| Percent Change From Baseline in Triglyceride (TG) at Each Visit | Week 4, 12, 24, and 52 | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 |
| Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Weeks 4, 12, 24, and 52 | Value at each visits minus value at baseline |
| Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Weeks 4, 12, 24, and 52 | Value at each visits minus value at baseline |
| Percent Change From Baseline in Apolipoprotein B at Each Visit | Week 4, 12, 24, and 52 | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Weeks 4, 12, 24, and 52 | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caduet Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after. | 159 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Difficulty of visit for complications | 1 |
| Overall Study | Participant was arrested | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Caduet |
|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 101 / 159 |
| serious Total, serious adverse events | 11 / 159 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: 52 weeks
Population: The safety analysis set included all participants who took at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caduet | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 120 Participants |
| Caduet | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 11 Participants |
Secondary
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline
Time frame: Weeks 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 12 (n=155) | -0.3 Ratio | Standard Deviation 0.7 |
| Caduet | Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 24 (n=151) | -0.3 Ratio | Standard Deviation 0.66 |
| Caduet | Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 4 (n=157) | -0.4 Ratio | Standard Deviation 0.7 |
| Caduet | Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 52 (n=144) | -0.4 Ratio | Standard Deviation 0.68 |
| Caduet | Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 52 (LOCF) (n=156) | -0.4 Ratio | Standard Deviation 0.68 |
Secondary
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline
Time frame: Weeks 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 4 (n=157) | -0.4 Ratio | Standard Deviation 0.77 |
| Caduet | Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 12 (n=156) | -0.4 Ratio | Standard Deviation 0.79 |
| Caduet | Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 24 (n=151) | -0.3 Ratio | Standard Deviation 0.76 |
| Caduet | Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 52 (n=145) | -0.4 Ratio | Standard Deviation 0.77 |
| Caduet | Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 52 (LOCF) (n=157) | -0.4 Ratio | Standard Deviation 0.77 |
Secondary
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment.~Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 32 (n=16) | -4.8 mmHg | Standard Deviation 9.56 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 36 (n=15) | -2.5 mmHg | Standard Deviation 6.2 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 52 (n=15) | -4.4 mmHg | Standard Deviation 6.75 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 52 (LOCF) (n=16) | -3.2 mmHg | Standard Deviation 8.29 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 2 (n=15) | 0.8 mmHg | Standard Deviation 8.21 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 4 (n=16) | -1.1 mmHg | Standard Deviation 4.96 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 8 (n=16) | -1.0 mmHg | Standard Deviation 6.19 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 12 (n=16) | -1.1 mmHg | Standard Deviation 6.86 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 16 (n=16) | -2.2 mmHg | Standard Deviation 7.12 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 20 (n=16) | -0.9 mmHg | Standard Deviation 6.71 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 24 (n=16) | -3.5 mmHg | Standard Deviation 6.69 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 28 (n=16) | -3.0 mmHg | Standard Deviation 6.55 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 40 (n=15) | -1.2 mmHg | Standard Deviation 8.53 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 44 (n=15) | -2.6 mmHg | Standard Deviation 9.06 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Week 48 (n=15) | -0.7 mmHg | Standard Deviation 5.18 |
Secondary
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 2 (n=140) | 0.3 mmHg | Standard Deviation 7.03 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 4 (n=139) | -0.4 mmHg | Standard Deviation 6.75 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 8 (n=140) | 0.2 mmHg | Standard Deviation 6.9 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 12 (n=140) | -0.2 mmHg | Standard Deviation 7.13 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 16 (n=138) | -0.7 mmHg | Standard Deviation 7.5 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 20 (n=136) | -1.8 mmHg | Standard Deviation 7.38 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 24 (n=134) | -1.6 mmHg | Standard Deviation 7.03 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 28 (n=132) | -2.6 mmHg | Standard Deviation 7.27 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 32 (n=132) | -3.5 mmHg | Standard Deviation 7.84 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 36 (n=132) | -4.3 mmHg | Standard Deviation 6.5 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 40 (n=132) | -3.2 mmHg | Standard Deviation 6.9 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 44 (n=130) | -2.5 mmHg | Standard Deviation 7.4 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 48 (n=130) | -2.0 mmHg | Standard Deviation 7.52 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 52 (n=129) | -0.6 mmHg | Standard Deviation 7.72 |
| Caduet | Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 52 (LOCF) (n=142) | -0.6 mmHg | Standard Deviation 7.68 |
Secondary
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 2 (n=140) | -0.2 mmHg | Standard Deviation 8.57 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 4 (n=139) | -0.6 mmHg | Standard Deviation 9.19 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 8 (n=140) | 0.0 mmHg | Standard Deviation 10.38 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 12 (n=140) | -0.4 mmHg | Standard Deviation 10.46 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 16 (n=138) | -1.5 mmHg | Standard Deviation 11.1 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 20 (n=136) | -2.8 mmHg | Standard Deviation 10.07 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 24 (n=134) | -1.8 mmHg | Standard Deviation 9.74 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 28 (n=132) | -3.1 mmHg | Standard Deviation 10.39 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 32 (n=132) | -4.8 mmHg | Standard Deviation 10.76 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 36 (n=132) | -4.8 mmHg | Standard Deviation 8.85 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 40 (n=132) | -4.4 mmHg | Standard Deviation 8.84 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 44 (n=130) | -4.0 mmHg | Standard Deviation 10.58 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 48 (n=130) | -2.3 mmHg | Standard Deviation 10.2 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 52 (n=129) | -1.5 mmHg | Standard Deviation 10.92 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Week 52 (LOCF) (n=142) | -1.5 mmHg | Standard Deviation 10.81 |
Secondary
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 2 (n=15) | -1.1 mmHg | Standard Deviation 11.57 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 4 (n=16) | -2.3 mmHg | Standard Deviation 8.68 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 8 (n=16) | -1.1 mmHg | Standard Deviation 7.76 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 12 (n=16) | -2.2 mmHg | Standard Deviation 9.11 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 16 (n=16) | -2.3 mmHg | Standard Deviation 13.49 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 20 (n=16) | -2.3 mmHg | Standard Deviation 8.47 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 24 (n=16) | -6.7 mmHg | Standard Deviation 9.07 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 28 (n=16) | -6.8 mmHg | Standard Deviation 10.23 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 32 (n=16) | -7.8 mmHg | Standard Deviation 10.79 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 36 (n=15) | -5.7 mmHg | Standard Deviation 9.72 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 40 (n=15) | -2.7 mmHg | Standard Deviation 10 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 44 (n=15) | -3.7 mmHg | Standard Deviation 11.38 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 48 (n=15) | -0.4 mmHg | Standard Deviation 9.44 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 52 (n=15) | -4.4 mmHg | Standard Deviation 13.08 |
| Caduet | Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Week 52 (LOCF) (n=16) | -3.1 mmHg | Standard Deviation 13.77 |
Secondary
Percent Change From Baseline in Apolipoprotein B at Each Visit
Value at each visits minus value at baseline divided by value at baseline multiplied by 100
Time frame: Week 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Percent Change From Baseline in Apolipoprotein B at Each Visit | Week 4 (n=157) | -9.2 Percentage of Apolipoprotein B | Standard Deviation 18.59 |
| Caduet | Percent Change From Baseline in Apolipoprotein B at Each Visit | Week 12 (n=156) | -5.8 Percentage of Apolipoprotein B | Standard Deviation 21.13 |
| Caduet | Percent Change From Baseline in Apolipoprotein B at Each Visit | Week 52 (n=145) | -9.1 Percentage of Apolipoprotein B | Standard Deviation 20.1 |
| Caduet | Percent Change From Baseline in Apolipoprotein B at Each Visit | Week 24 (n=151) | -7.4 Percentage of Apolipoprotein B | Standard Deviation 20.99 |
| Caduet | Percent Change From Baseline in Apolipoprotein B at Each Visit | Week 52 (LOCF) (n=157) | -9.3 Percentage of Apolipoprotein B | Standard Deviation 19.84 |
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline divided by value at baseline multiplied by 100
Time frame: Weeks 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 4 (n=157) | 1.5 Percentage of HDL-C | Standard Deviation 10.63 |
| Caduet | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 12 (n=156) | 4.0 Percentage of HDL-C | Standard Deviation 13.91 |
| Caduet | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 24 (n=151) | -0.5 Percentage of HDL-C | Standard Deviation 13.26 |
| Caduet | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 52 (n=145) | 2.2 Percentage of HDL-C | Standard Deviation 11.47 |
| Caduet | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Week 52 (LOCF) (n=157) | 2.5 Percentage of HDL-C | Standard Deviation 11.69 |
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Value at each visits minus value at baseline divided by value at baseline multiplied by 100
Time frame: Weeks 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Week 4 (n=157) | -10.9 Percentage of LDL-C | Standard Deviation 23.87 |
| Caduet | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Week 12 (n=155) | -7.4 Percentage of LDL-C | Standard Deviation 25.66 |
| Caduet | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Week 24 (n=151) | -10.5 Percentage of LDL-C | Standard Deviation 24.04 |
| Caduet | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Week 52 (n=144) | -12.3 Percentage of LDL-C | Standard Deviation 23.62 |
| Caduet | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Week 52 (LOCF) (n=156) | -12.2 Percentage of LDL-C | Standard Deviation 23.55 |
Secondary
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Value at each visits minus value at baseline divided by value at baseline multiplied by 100
Time frame: Weeks 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Week 24 (n=151) | -7.9 Percentage of TC | Standard Deviation 16.78 |
| Caduet | Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Week 52 (n=145) | -8.0 Percentage of TC | Standard Deviation 16.37 |
| Caduet | Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Week 52 (LOCF) (n=157) | -8.1 Percentage of TC | Standard Deviation 16.04 |
| Caduet | Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Week 4 (n=157) | -7.3 Percentage of TC | Standard Deviation 15.9 |
| Caduet | Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Week 12 (n=156) | -5.0 Percentage of TC | Standard Deviation 17.03 |
Secondary
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Value at each visits minus value at baseline divided by value at baseline multiplied by 100
Time frame: Week 4, 12, 24, and 52
Population: The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Percent Change From Baseline in Triglyceride (TG) at Each Visit | Week 4 (n=157) | 8.2 Percentage of TG | Standard Deviation 52.47 |
| Caduet | Percent Change From Baseline in Triglyceride (TG) at Each Visit | Week 12 (n=156) | 3.6 Percentage of TG | Standard Deviation 49.94 |
| Caduet | Percent Change From Baseline in Triglyceride (TG) at Each Visit | Week 24 (n=151) | 6.4 Percentage of TG | Standard Deviation 45.75 |
| Caduet | Percent Change From Baseline in Triglyceride (TG) at Each Visit | Week 52 (n=145) | 8.5 Percentage of TG | Standard Deviation 62.03 |
| Caduet | Percent Change From Baseline in Triglyceride (TG) at Each Visit | Week 52 (LOCF) (n=157) | 7.2 Percentage of TG | Standard Deviation 60.92 |