Status:
COMPLETED
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypertension
Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT01190007
Start Date
August 1 2010
End Date
February 1 2012
Last Update
January 28 2021
Active Locations (20)
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1
Healthcare Corporation MEDOC Medical Dock&Clinic
Nagoya, Aichi-ken, Japan
2
Beppu Medical Clinic
Dazaifu, Fukuoka, Japan
3
Morizono medical clinic
Kitakyushu, Fukuoka, Japan
4
Gakkentoshi Clinic
Nishiku, Fukuoka, Japan