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

Last updated: January 26, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

4

Condition

Chest Pain

Heart Disease

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT01190007
A3841064
  • Ages > 20
  • All Genders

Study 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

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 3months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, andTG < 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 3months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, andTG < 400 mg/dL at Week -2

Exclusion

Exclusion Criteria:

  • Subjects who need three or more multi-antihypertensive therapies to achieve the targetBP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level isdefined 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

Study Design

Total Participants: 159
Study Start date:
August 01, 2010
Estimated Completion Date:
February 29, 2012

Connect with a study center

  • Healthcare Corporation MEDOC Medical Dock&Clinic

    Nagoya, Aichi
    Japan

    Site Not Available

  • Beppu Medical Clinic

    Dazaifu, Fukuoka
    Japan

    Site Not Available

  • Morizono medical clinic

    Kitakyushu, Fukuoka
    Japan

    Site Not Available

  • Gakkentoshi Clinic

    Nishi-ku, Fukuoka
    Japan

    Site Not Available

  • Department of internal gastro-intestinal medicine Ohshima clinic

    Sapporo, Hokkaido
    Japan

    Site Not Available

  • Oofuji Clinic

    Amagasaki, Hyogo
    Japan

    Site Not Available

  • Mizutani Clinic

    Kobe, Hyogo
    Japan

    Site Not Available

  • Nada Clinic

    Kobe, Hyogo
    Japan

    Site Not Available

  • Idaimae-naika Clinic

    Kawasaki, Kanagawa
    Japan

    Site Not Available

  • Sakakibara Clinic, Wakaumekai Medical Corporation

    Yokohama, Kanagawa
    Japan

    Site Not Available

  • Masunaga Clinic

    Fujimi, Saitama
    Japan

    Site Not Available

  • Sugiura Clinic

    Kawaguchi, Saitama
    Japan

    Site Not Available

  • Masuda Clinic

    Adachi-ku, Tokyo
    Japan

    Site Not Available

  • Wakasugi Family Clinic

    Arakawa-ku, Tokyo
    Japan

    Site Not Available

  • Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic

    Koto-ku, Tokyo
    Japan

    Site Not Available

  • Banno Clinic

    Ohta-ku, Tokyo
    Japan

    Site Not Available

  • Hatano Medical Clinic

    Setagaya-ku, Tokyo
    Japan

    Site Not Available

  • Suzuki Circulatory Medical Clinic

    Setagaya-ku, Tokyo
    Japan

    Site Not Available

  • Yano Cardiovascular Clinic

    Fukuoka,
    Japan

    Site Not Available

  • Nakaoka Clinic

    Osaka,
    Japan

    Site Not Available

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