Clinical trial NCT01190007: Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Hypercholesterolemia
Angina Pectoris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
timeFrame: Weeks 4, 12, 24, and 52
measure: Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
timeFrame: Weeks 4, 12, 24, and 52
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
timeFrame: Weeks 4, 12, 24, and 52
measure: Percent Change From Baseline in Triglyceride (TG) at Each Visit
timeFrame: Week 4, 12, 24, and 52
measure: Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
timeFrame: Weeks 4, 12, 24, and 52
measure: Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
timeFrame: Weeks 4, 12, 24, and 52
measure: Percent Change From Baseline in Apolipoprotein B at Each Visit
timeFrame: Week 4, 12, 24, and 52
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Healthcare Corporation MEDOC Medical Dock&Clinic
state: Aichi
city: Dazaifu
country: Japan
facility: Beppu Medical Clinic
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Morizono medical clinic
state: Fukuoka
city: Nishi-ku
country: Japan
facility: Gakkentoshi Clinic
state: Fukuoka
city: Sapporo
country: Japan
facility: Department of internal gastro-intestinal medicine Ohshima clinic
state: Hokkaido
city: Amagasaki
country: Japan
facility: Oofuji Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Mizutani Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Nada Clinic
state: Hyogo
city: Kawasaki
country: Japan
facility: Idaimae-naika Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Sakakibara Clinic, Wakaumekai Medical Corporation
state: Kanagawa
city: Fujimi
country: Japan
facility: Masunaga Clinic
state: Saitama
city: Kawaguchi
country: Japan
facility: Sugiura Clinic
state: Saitama
city: Adachi-ku
country: Japan
facility: Masuda Clinic
state: Tokyo
city: Arakawa-ku
country: Japan
facility: Wakasugi Family Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic
state: Tokyo
city: Ohta-ku
country: Japan
facility: Banno Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Hatano Medical Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Suzuki Circulatory Medical Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Yano Cardiovascular Clinic
city: Osaka
country: Japan
facility: Nakaoka Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: