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

NCT ID: NCT01190007

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-02-29

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.

Conditions

Hypertension; Hypercholesterolemia; Angina Pectoris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Caduet

Group Type: EXPERIMENTAL

Caduet

Intervention Type: DRUG

One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

Interventions

Caduet

One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Healthcare Corporation MEDOC Medical Dock&Clinic

Nagoya, Aichi-ken, Japan

Beppu Medical Clinic

Dazaifu, Fukuoka, Japan

Morizono medical clinic

Kitakyushu, Fukuoka, Japan

Gakkentoshi Clinic

Nishiku, Fukuoka, Japan

Department of internal gastro-intestinal medicine Ohshima clinic

Sapporo, Hokkaido, Japan

Oofuji Clinic

Amagasaki, Hyōgo, Japan

Mizutani Clinic

Kobe, Hyōgo, Japan

Nada Clinic

Kobe, Hyōgo, 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

Yano Cardiovascular Clinic

Fukuoka, , Japan

Nakaoka Clinic

Osaka, , Japan

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841064&StudyName=Open%20Label%20Study%20To%20Evaluate%20The%20Long-Term%20Safety%20Profiles%20Of%20Caduet%20In%20Japanese%20Patients

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

Other Identifiers

A3841064

Identifier Type: -

Identifier Source: org_study_id