Phase 4
Completed N=159
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Hypertension · Hypercholesterolemia · Angina Pectoris
Source: ClinicalTrials.gov NCT01190007 ↗
Enrolled (actual)
159
Serious AEs
6.9%
Results posted
Dec 2012
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 120; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
120; 11 | — |
| SECONDARY Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia |
-0.2; -0.6; 0.0; -0.4; -1.5; -2.8 | — |
| SECONDARY Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia |
-1.1; -2.3; -1.1; -2.2; -2.3; -2.3 | — |
| SECONDARY Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia |
0.3; -0.4; 0.2; -0.2; -0.7; -1.8 | — |
| SECONDARY Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia |
0.8; -1.1; -1.0; -1.1; -2.2; -0.9 | — |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit |
-10.9; -7.4; -10.5; -12.3; -12.2 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol (TC) at Each Visit |
-7.3; -5.0; -7.9; -8.0; -8.1 | — |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit |
1.5; 4.0; -0.5; 2.2; 2.5 | — |
| SECONDARY Percent Change From Baseline in Triglyceride (TG) at Each Visit |
8.2; 3.6; 6.4; 8.5; 7.2 | — |
| SECONDARY Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit |
-0.4; -0.3; -0.3; -0.4; -0.4 | — |
| SECONDARY Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit |
-0.4; -0.4; -0.3; -0.4; -0.4 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Each Visit |
-9.2; -5.8; -7.4; -9.1; -9.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01190007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.