Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

Condition(s) targeted: Hypertension; Hypercholesterolemia; Angina Pectoris

Intervention: Caduet (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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: Assessment of long-term safety profile based on AEs, clinical laboratory test, ECG, pulse rate and angina condition

Secondary outcome:

Change from baseline in trough systolic blood pressure (SBP) at each visit

Change from baseline in trough diastolic blood pressure (DBP) at each visit

Percent change from baseline in LDL-C at each visit

Percent change from baseline in TC at each visit

Percent change from baseline in HDL-C at each visit

Percent change from baseline in TG at each visit

Change from baseline in ratio of LDL-C to HDL-C at each visit

Change from baseline in ratio of TC to HDL-C at each visit

Percent change from baseline in apolipoprotein B at each visit

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Oofuji Clinic, Amagasaki, Hyogo, Japan; Recruiting
Hidenori Ono, Email: ono6413@yahoo.co.jp

Nada Clinic, Kobe, Hyogo, Japan; Recruiting
Masaharu Murakami, Email: chiken.nada.m@gmail.com

Idaimae-naika Clinic, Kawasaki, Kanagawa, Japan; Not yet recruiting
Megumi Noguchi, Email: idaimae_noguchi@yahoo.co.jp

Banno Clinic, Ohta-ku, Tokyo, Japan; Recruiting
Masae Banno, Email: banno@banno-clinic.com

Suzuki Circulatory Medical Clinic, Setagaya-ku, Tokyo, Japan; Recruiting
Shin Suzuki, Phone: 03-3412-0072

To obtain contact information for a study center near you, click here.

Starting date: August 2010
Last updated: September 17, 2010