Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Hypercholesterolemia; Angina Pectoris
Intervention: Caduet (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome: Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and HypercholesterolemiaChange From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit Percent Change From Baseline in Total Cholesterol (TC) at Each Visit Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit Percent Change From Baseline in Triglyceride (TG) at Each Visit Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit Percent Change From Baseline in Apolipoprotein B at Each Visit
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Yano Cardiovascular Clinic, Fukuoka, Japan
Nakaoka Clinic, Osaka, Japan
Healthcare Corporation MEDOC Medical Dock&Clinic, Nagoya, Aichi, Japan
Beppu Medical Clinic, Dazaifu, Fukuoka, Japan
Morizono medical clinic, Kitakyushu, Fukuoka, Japan
Gakkentoshi Clinic, Nishi-ku, Fukuoka, Japan
Department of internal gastro-intestinal medicine Ohshima clinic, Sapporo, Hokkaido, Japan
Oofuji Clinic, Amagasaki, Hyogo, Japan
Mizutani Clinic, Kobe, Hyogo, Japan
Nada Clinic, Kobe, Hyogo, Japan
Idaimae-naika Clinic, Kawasaki, Kanagawa, Japan
Sakakibara Clinic, Wakaumekai Medical Corporation, Yokohama, Kanagawa, Japan
Masunaga Clinic, Fujimi, Saitama, Japan
Sugiura Clinic, Kawaguchi, Saitama, Japan
Masuda Clinic, Adachi-ku, Tokyo, Japan
Wakasugi Family Clinic, Arakawa-ku, Tokyo, Japan
Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic, Koto-ku, Tokyo, Japan
Banno Clinic, Ohta-ku, Tokyo, Japan
Hatano Medical Clinic, Setagaya-ku, Tokyo, Japan
Suzuki Circulatory Medical Clinic, Setagaya-ku, Tokyo, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2010
Last updated: December 19, 2012
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