Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments (POSITIVE)

This study has been terminated.
(With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study.)
Sponsor:
Information provided by:
Positive Trial Group
ClinicalTrials.gov Identifier:
NCT01173939
First received: July 27, 2010
Last updated: May 30, 2011
Last verified: November 2010
  Purpose

The study is being conducted to compare the effect of standard treatment (target LDL-C level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.


Condition Intervention
Hypercholesterolemia
Type 2 Diabetes
Hypertension
Drug: Pravastatin
Drug: Rosuvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension

Resource links provided by NLM:


Further study details as provided by Positive Trial Group:

Primary Outcome Measures:
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: No ]
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: No ]
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: No ]
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: No ]
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: No ]
  • MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event [ Time Frame: At the end of the study or discontinuation up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevention of individual MACE [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Prevention of individual MACE [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of individual MACE [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of individual MACE [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of individual MACE [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of individual MACE [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of individual MACE [ Time Frame: At the end of the study (or discontinuation) ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention of MACE(combination of each category) [ Time Frame: At the end of the study (or discontinuation) ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) [ Time Frame: At study completion up to 4 years ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") [ Time Frame: At the end of the study or discontinuation up to 4 years ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of deaths during the study period [ Time Frame: At the end of the study or discontinuation up to 4 years ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and distribution of type of hospitalizations during the study period [ Time Frame: At the end of the study or discontinuation up to 4 years ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency of other events (malignancy, dementia, need of nursing care) [ Time Frame: At the end of the study or discontinuation up to 4 years ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: 1 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: 3 month after treatment initiation ] [ Designated as safety issue: No ]
  • Frequency and type of adverse events [ Time Frame: 6 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: 12 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: 36 month after treatment initiation ] [ Designated as safety issue: Yes ]
  • Frequency and type of adverse events [ Time Frame: At the end of the study or discontinuation up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10000
Study Start Date: July 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active comparator: Standard Pravastatin Group Drug: Pravastatin
5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)
Active Comparator: Intensive Rosuvastatin Group Drug: Rosuvastatin
5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients meeting the following inclusion criteria will be included in the study:

  1. Patients giving voluntary written consent to participate in the study
  2. Male or female patients 50 years of age or older (at informed consent)
  3. Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
  4. Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
  5. Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)
  6. Patients with two or more of the following risk factors

    • Male
    • 65 years of age or older
    • Smoker
    • L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
    • Left ventricular hypertrophy
    • First- or second-degree family history of MACE
    • Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2)

Exclusion Criteria:

Patients meeting the following criteria will be excluded from the study:

  1. Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
  2. Patients judged to have familial hypercholesterolemia
  3. Patients with a serum triglyceride level of ≥400 mg/dL
  4. Patients with a history of myocardial infarction
  5. Patients with a history of coronary revascularization (PCI or CABG)
  6. Patients with a history of treatment of unstable angina
  7. Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
  8. Heart failure patients
  9. Patients with a history of hypersensitivity to statins
  10. Patients with a history of drug-induced myopathy
  11. Patients with poorly controlled arrhythmia
  12. Patients with severe liver or kidney disease
  13. Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
  14. Patients who are or may be pregnant
  15. Patients judged by the investigators to be ineligible for participation in the study for any other reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173939

  Hide Study Locations
Locations
Japan
Medical Dock&Clinic
Nagoya city, Aichi pref., Japan
Hiramitsu Heart Clinic
Nagoya city, Aichi pref., Japan
Matsuno Medical Clinic
Iyo gun, Ehime pref., Japan
Ishite Matsumoto Naika Junkanki Clinic
Matsuyama city, Ehime pref., Japan
Ehime Medical CO-OP Izumigawa Clinic
Niihama city, Ehime pref., Japan
Tsugawa Internal Medicine Clinic
Echizen city, Fukui pref., Japan
Fukui Chuo Clinic
Fukui city, Fukui pref., Japan
Koshino Clinic
Sakai city, Fukui pref., Japan
Fukuoka University Chikushi Hospital
Chikushino city, Fukuoka pref., Japan
Saiseikai Futsukaichi Hospital
Chikushino city, Fukuoka pref., Japan
Abies Clinic
Fukuoka city, Fukuoka pref., Japan
Saku Hospital
Fukuoka city, Fukuoka pref., Japan
Naitoh Clinic
Fukuoka city, Fukuoka pref., Japan
Hirano Medical Clinic
Fukuoka city, Fukuoka pref., Japan
Fukuoka Tokushukai Medical Center
Kasuga city, Fukuoka pref., Japan
Morizono Naika
Kitakyusyu city, Fukuoka pref., Japan
Kawai Naika Clinic
Gifu city, Gifu pref., Japan
Hiroshima General Hospital of West Japan Railway Company
Hiroshima city, Hiroshima pref., Japan
Hijirigaoka Hospital
Date city, Hokkaido pref., Japan
Kyoaikai Hospital
Hakodate city, Hokkaido pref., Japan
Miyazawa Cardiovascular And Internal Medicine Clinic
Kato-gun, Hokkaido pref., Japan
Jiyugaoka Yamada Clinic
Obihiro city, Hokkaido pref., Japan
Chikama Clinic
Sapporo city, Hokkaido pref., Japan
Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital
Sapporo city, Hokkaido pref., Japan
Seiwa Memorial Hospital
Sapporo city, Hokkaido pref., Japan
Hiro Clinic
Sapporo city, Hokkaido pref., Japan
Medical Treatment Corporate Foundation Yubari Kibounomori Yubari City Clinic
Yubari city, Hokkaido pref., Japan
Ino Hospital
Himeji city, Hyogo pref., Japan
Katsuya Clinic
Amagasaki city, Hyogo pref, Japan
Shimizu Clinic
Kobe city, Hyogo pref, Japan
Kotani Diabetes Clinic
Kobe city, Hyogo pref, Japan
Dr. Kodama's Office of Internal Medicine
Nishinomiya city, Hyogo pref, Japan
Koga Hospital
Koga city, Ibaraki pref., Japan
Yanagi Medical Clinic
Hakusan city, Ishikawa pref., Japan
Imura Internal Medicine Clinic
Hakusan city, Ishikawa pref., Japan
Okyozuka Clinic
Ishikawa gun, Ishikawa pref., Japan
Murata Clinic
Kahoku gun, Ishikawa pref., Japan
Koni Clinic
Kahoku gun, Ishikawa pref., Japan
Arai Naika Clinic
Kanazawa city, Ishikawa pref., Japan
Wakasa Medical Clinic
Kanazawa city, Ishikawa pref., Japan
Dr. Hayakawa's Family Clinic
Kanazawa city, Ishikawa pref., Japan
Morita Hospital
Komatsu city, Ishikawa pref., Japan
Kawasaki Family Clinic
Ichinoseki, Iwate pref., Japan
Sugie Clinic
Iwate gun, Iwate pref., Japan
Katsura General Clinic
Morioka city, Iwate pref., Japan
Takamiya General Clinic
Shiwa gun, Iwate pref., Japan
Hayashi Clinic
Marugame city, Kagawa pref., Japan
Otsuka Internal Medicine Clinic
Marugame city, Kagawa pref., Japan
Matsuoka Clinic
Takamatsu city, Kagawa pref., Japan
Center for Preventive Medical Treatment, NTT West Takamatsu Hospital
Takamatsu city, Kagawa pref., Japan
Hasegawa Outpatients Clinic for Cardiovascular Disease
Takamatsu city, Kagawa pref., Japan
Kojima Clinic
Takamatsu city, Kagawa pref., Japan
Hananomiya Clinic
Takamatsu city, Kagawa pref., Japan
Osumi-Kanoya Hospital
Kanoya city, Kagoshima pref., Japan
Yakushima Tokushukai Hospital
Kumage gun, Kagoshima pref., Japan
Nemoto G.I.M. Clinic
Ashigara-kami gun, Kanagawa pref., Japan
Magokoro Internal Medicine and Orthopedic Clinic
Ashigarakami gun, Kanagawa pref., Japan
Kasuya Clinic
Atsugi City, Kanagawa pref., Japan
Takahashi Clinic
Fujisawa city, Kanagawa pref., Japan
Kuboshima Clinic
Fujisawa city, Kanagawa pref., Japan
Akizawa Clinic
Isehara city, Kanagawa pref., Japan
Medical Corp Takeda Clinic
Isehara city, Kanagawa pref., Japan
Iroden Clinic
Kamakura city, Kanagawa pref., Japan
Hashimoto Clinic
Kamakura city, Kanagawa pref., Japan
Shohei Clinic
Kamakura city, Kanagawa pref., Japan
Kamakura Naika Shinryosyo
Kamakura city, Kanagawa pref., Japan
Hatori Medical Clinic
Kawasaki city, Kanagawa pref., Japan
Kirimura Iin
Kawasaki city, Kanagawa pref., Japan
Kamegaya Medical Clinic
Kawasaki city, Kanagawa pref., Japan
Hirayasu Iin
Kawasaki city, Kanagawa pref., Japan
Kojima Clinic
Odawara city, Kanagawa pref., Japan
Hakuai Iin
Sagamihara city, Kanagawa pref., Japan
Toshiba Rinkan Hospital
Sagamihara city, Kanagawa pref., Japan
Sato Clinic
Sagamihara city, Kanagawa pref., Japan
Yamamoto Clinic
Sagamihara city, Kanagawa pref., Japan
Shinyoshida Clinic
Yokohama city, Kanagawa pref., Japan
Shinwakai Fukuda Iin
Yokohama city, Kanagawa pref., Japan
Yokohama Sotetsu bldg. clinic of internal medicine
Yokohama city, Kanagawa pref., Japan
Fukushi Clinic
Yokohama city, Kanagawa pref., Japan
Yokohama City University Medical Center
Yokohama city, Kanagawa pref., Japan
Kikuchi Clinic
Yokohama city, Kanagawa pref., Japan
Minamisawa Clinic
Yokohama city, Kanagawa pref., Japan
Miyoshi-Clinic
Yokohama city, Kanagawa pref., Japan
Matsuo Naika Clinic
Yokohama city, Kanagawa pref., Japan
International Goodwill Hospital
Yokohama city, Kanagawa pref., Japan
Shimokurata Heart Clinic
Yokohama city, Kanagawa pref., Japan
Suzuki Orthopedic Clinic
Yokohama city, Kanagawa pref., Japan
Paula's Clinic
Yokohama city, Kanagawa pref., Japan
Fukumura Clinic
Yokohama city, Kanagawa pref., Japan
Miho-cho Cardiovascular Medical Clinic
Yokohama city, Kanagawa pref., Japan
Hara Clinic
Yokosuka City, Kanagawa pref., Japan
Ueta Medical Clinic
Kochi city, Kochi pref., Japan
Yamashita Clinic
Amakusa city, Kumamoto pref., Japan
Nakayama Cardiovascular Clinic
Amakusa city, Kumamoto pref., Japan
National Health Insurance Central Hospital Aso
Aso city, Kumamoto pref., Japan
Sakanashi Heart Clinic
Aso city, Kumamoto pref., Japan
Koyasako iin
Kamimashiki gun, Kumamoto pref., Japan
Kawaguchi Hospital
Kikuchi city, Kumamoto pref., Japan
Miyamoto Internal Clinic
Kikuchi city, Kumamoto pref., Japan
Suizenji Tohya Hospital
Kumamoto city, Kumamoto pref., Japan
Yi Medical Clinic
Kumamoto city, Kumamoto pref., Japan
Haraguchi Circular&Internal Medical Clinic
Kumamoto city, Kumamoto pref., Japan
Terao Hospital
Kumamoto city, Kumamoto pref., Japan
Ootsuka Hospital
Kumamoto city, Kumamoto pref., Japan
Doi Naika-ichoka Clinic
Kumamoto city, Kumamoto pref., Japan
Suefuji Naika Junkankika
Kumamoto city, Kumamoto pref., Japan
Nozuhara Clinic
Kumamoto city, Kumamoto pref., Japan
Doi Cardiovascular Clinic
Kumamoto city, Kumamoto pref., Japan
Kiyota Junkanki Naika Iin
Kumamoto city, Kumamoto pref., Japan
Jinnouchi Clinic Diabetes Care Center
Kumamoto city, Kumamoto pref., Japan
Shono Heart Clinic
Kumamoto city, Kumamoto pref., Japan
Maki Cardiovascular Clinic
Kumamoto city, Kumamoto pref., Japan
Munakata Clinic
Shimomashiki gun, Kumamoto pref., Japan
Higashi Diabetes and Cardiovascular Clinic
Tamana city, Kumamoto pref., Japan
Yoshimura Jyunnkannkika Naika Iinn
Tamana city, Kumamoto pref., Japan
Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary
Tamana gun, Kumamoto pref., Japan
Miyagi Clinic Cardiovascular Medicine
Yatsushiro city, Kumamoto pref., Japan
Koide Iin
Kizugawa-city, Kyoto pref., Japan
Sawai medical Clinic
Kyotanabe city, Kyoto pref., Japan
Tegoshi Clinic
Kyoto city, Kyoto pref., Japan
Omoto Clinic
Kyoto city, Kyoto pref., Japan
Sakazaki Clinic
Kyoto city, Kyoto pref., Japan
Takagi Cardiology Clinic
Kyoto city, Kyoto pref., Japan
Takenaka Clinic
Kyoto city, Kyoto pref., Japan
Asamoto Clinic of Internal Medicine
Kyoto city, Kyoto pref., Japan
Gotoh Clinic
Kyoto city, Kyoto pref., Japan
Isoda Internal Medical Clinic
Kyoto city, Kyoto pref., Japan
Shinya Clinic
Kyoto city, Kyoto pref., Japan
Higashiyama Takeda Hospital
Kyoto city, Kyoto pref., Japan
Kimura Naika Clinic
Yosa gun, Kyoto pref., Japan
Shimizu Clinic
Ise city, Mie pref., Japan
Horii Clinic Kiodai
Nabari city, Mie pref., Japan
Yamoto-naika Clinic
Higashi matsushima city, Miyagi pref., Japan
Seisuikai Yoshioka QQ Clinic
Kurokawa gun, Miyagi pref., Japan
Ohtomo Clinic
Tome City, Miyagi pref., Japan
Shimoina Kosei Hospital
Shimoina gun, Nagano pref., Japan
Yokoyama Medical Clinic
Shiojiri city, Nagano pref., Japan
Sato Clinic
Suzaka city, Nagano pref., Japan
Hoshiko Clinic
Nagasaki city, Nagasaki pref., Japan
Shinagawa Clinic
Nagasaki city, Nagasaki pref., Japan
Iryohojin Yamamoto Naika
Nishisonogi gun, Nagasaki pref., Japan
Yamada Clinic
Gojo city, Nara pref., Japan
Uyama Naika Clinic
Ikoma city, Nara pref., Japan
Clinic Jinguumae
Kahihara city, Nara pref., Japan
Kasahara Clinic
Kahihara city, Nara pref., Japan
Sawada Clinic
Kashiba city, Nara pref., Japan
Miyamoto Clinic
Kashihara city, Nara pref., Japan
Oosumi Naika Iin
Kashihara city, Nara pref., Japan
Doi Clinic
Kashihara city, Nara pref., Japan
Medical Corporation Kiriyama Clinic
Kashihara city, Nara pref., Japan
Kondo Clinic Mamigaoka Purified Center
Kitakatsuragi gun, Nara pref., Japan
Seiwadai Clinic
Kitakatsuragi gun, Nara pref., Japan
Nakahori Iin
Kitakatsuragi gun, Nara pref., Japan
Matsuoka Clinic
Kitakatsuragi gun, Nara pref., Japan
Takanohara Suzuran-naika
Nara city, Nara pref., Japan
Saiseikai Nara Hospital
Nara city, Nara pref., Japan
Takanohara Central Hospital
Nara city, Nara pref., Japan
Sakaguchi Clinic
Sakurai city, Nara pref., Japan
Ote Clinic of Internal Medicine
Sakurai city, Nara pref., Japan
Kokuho Central Hospital
Shiki gun, Nara pref., Japan
Matsuta Heart Clinic
Yamatokoriyama city, Nara pref., Japan
Makiura Naika
Yamatokoriyama city, Nara pref., Japan
Nakatani Clinic
Yamatotakada city, Nara pref., Japan
Sano Clinic
Murakami city, Niigata pref., Japan
Kawaguchi Clinic
Nagaoka city, Niigata pref., Japan
Maeda Medical Clinic
Niigata city, Niigata pref., Japan
Watanabe NJ Clinic
Beppu city, Oiat pref., Japan
Tsuzaki Clinic
Oita city, Oiat pref., Japan
Tokumaru Digestive Internal Medicine Clinic
Oita city, Oiat pref., Japan
Ninomiya Clinic
Oita city, Oiat pref., Japan
Hirata Clinic
Oita city, Oiat pref., Japan
Sumi Cardiology Clinic
Oita city, Oiat pref., Japan
Ishida Medical Clinic
Usa city, Oiat pref., Japan
Inada Clinic
Kurashiki city, Okayama pref., Japan
Hachiouji Naika Clinic
Kurashiki city, Okayama pref., Japan
Yuhara Naika Clinic
Okayama city, Okayama pref., Japan
Hisamatsu Medical Clinic
Okayama city, Okayama pref., Japan
Hattori Clinic
Setouchi city, Okayama pref., Japan
Nishimura Clinic
Fujiidera city, Osaka pref., Japan
Ikeda Clinic
Higashiosaka city, Osaka pref., Japan
Ogawa Clinic
Higashiosaka city, Osaka pref., Japan
Taisei Clinic
Hirakata city, Osaka pref., Japan
Masuda Clinic
Ibaraki city, Osaka pref., Japan
Ishiga Clinic
Ibaraki city, Osaka pref., Japan
Kanazawa Clinic
Izumi city, Osaka pref., Japan
Misugi Clinic
Kaizuka city, Osaka pref., Japan
Yoshida Clinic
Kaizuka city, Osaka pref., Japan
Mori Iin
Kishiwada city, Osaka pref., Japan
Medical Corporation Joukokai Teranishi-geka naika
Moriguchi city, Osaka pref., Japan
Tai Internal Medicin Clinic
Osaka city, Osaka pref., Japan
Nishizawa Clinic
Osaka city, Osaka pref., Japan
Kubota Clinic
Osaka city, Osaka pref., Japan
Keiju Hospital
Osaka city, Osaka pref., Japan
Iryouhoujin Suisyoukai Murata Hospital
Osaka city, Osaka pref., Japan
Matsushita Medical Clinic
Osaka city, Osaka pref., Japan
Osaka General Medical Center
Osaka city, Osaka pref., Japan
Ueda Clinic
Osaka city, Osaka pref., Japan
Izuoka Clinic
Osaka city, Osaka pref., Japan
Senpuku Clinic
Osaka city, Osaka pref., Japan
Kondo Clinic
Osaka city, Osaka pref., Japan
Ohta Iin
Sakai city, Osaka pref., Japan
Iryohojin Nogi Naika Iin
Suita city, Osaka pref., Japan
Kobayashi Clinic
Suita city, Osaka pref., Japan
Ban Clinic
Suita city, Osaka pref., Japan
Ichida Internal Clinic
Takaishi city, Osaka pref., Japan
Yada Clinic
Takaishi city, Osaka pref., Japan
Ryo Clinic
Takatsuki city, Osaka pref., Japan
Matsuo Clinic
Yao city, Osaka pref., Japan
Enomoto Clinic
Ageo city, Saitama pref., Japan
Medimo Hanyu Clinic
Hanyu city, Saitama pref., Japan
Hirose Hospital
Kawagoe city, Saitama pref., Japan
Tokutake Iin
Kawaguchi city, Saitama pref., Japan
Iryohojin Hogi Shinryojo
Kawaguchi city, Saitama pref., Japan
Gamo Tenjinbashi Clinic
Koshigaya city, Saitama pref., Japan
Matsumoto Clinic
Koshigaya city, Saitama pref., Japan
Medical Corporation Shibuya Clinic
Kumagaya city, Saitama pref., Japan
Iwatsuki-minami Hospital
Saitama city, Saitama pref., Japan
Akimoto Clinic
Saitama city, Saitama pref., Japan
Suzuhiro Clinic
Saitama city, Saitama pref., Japan
Nashida naika clinic
Tokorozawa City, Saitama pref., Japan
Shizuoka Medical Alliance Shirahama Chuou Clinic
Shimoda city, Shizuoka pref., Japan
Aoshima Clinic
Shizuoka city, Shizuoka pref., Japan
Akiyama Clinic
Shizuoka city, Shizuoka pref., Japan
Eguchi Clinic
Shizuoka city, Shizuoka pref., Japan
Shizuoka Hospital
Shizuoka city, Shizuoka pref., Japan
Ueno Clinic
Yaizu city, Shizuoka pref., Japan
Takahashi Medical Clinic
Ohtawara city, Tochigi pref., Japan
Iryouhoujin Yuukoukai Morioka Naika Shonika
Oyama city, Tochigi pref., Japan
Takada Clinic
Tochigi city, Tochigi pref., Japan
Masuda Naika
Utsunomiya city, Tochigi pref., Japan
Murakami Clinic
Anan city, Tokushima pref., Japan
Yamamoto Naika Ityoka
Itano gun, Tokushima pref., Japan
Fukushima Clinic
Itano gun, Tokushima pref., Japan
Yuki National Health Insurance Hospital Of Minami Town
Kaifu gun, Tokushima pref., Japan
Sekishinkan Hospital
Komatsushima city, Tokushima pref., Japan
Ueta Clinic
Myozai gun, Tokushima pref., Japan
Yokoi Internal Medicine
Tokushima city, Tokushima pref., Japan
Kensei Uchimachi Clinic
Tokushima city, Tokushima pref., Japan
Okagawa Clinic
Tokushima city, Tokushima pref., Japan
Kitasako Clinic
Tokushima city, Tokushima pref., Japan
Matsumura Internal, Gastrointestial Medicine
Tokushima city, Tokushima pref., Japan
Kitagawa Naika Ityoka
Tokushima city, Tokushima pref., Japan
Limbs Tokushima Clinic
Tokushima city, Tokushima pref., Japan
Yata Clinic
Yoshinokawa city, Tokushima pref., Japan
Kimura Internal Medicine Clinic
Yoshinokawa city, Tokushima pref., Japan
Okubo Clinic
Akishima city, Tokyo, Japan
Juntendo University Hospital
Bunkyo ku, Tokyo, Japan
Choei Clinic
Edogawa ku, Tokyo, Japan
Shiraishi Iin
Edogawa ku, Tokyo, Japan
Utsugidai Tajima Clinic
Hachioji City, Tokyo, Japan
Hattori Clinic
Hachioji city, Tokyo, Japan
Toyoizumi Hospital
Hachioji city, Tokyo, Japan
Nishio Clinic
Itabashi ku, Tokyo, Japan
Mochizuki Naika Clinic
Itabashi ku, Tokyo, Japan
Ono Heart Clinic
Koto ku, Tokyo, Japan
Shiba Palace Clinic
Minato-ku, Tokyo, Japan
Tenjinmae Clinic
Mitaka city, Tokyo, Japan
Kamada Clinic
Mitaka city, Tokyo, Japan
Takayama Iin
Mitaka-shi, Tokyo, Japan
Sugawara Clinic
Nerima ku, Tokyo, Japan
Yamada Clinic
Ota-ku, Tokyo, Japan
Matsumura Gastroenterological Clinic
Setagaya ku, Tokyo, Japan
Yotsuya-Murakami Internal Medicine Clinic
Shinjuku ku, Tokyo, Japan
Magari Clinic
Shinjuku ku, Tokyo, Japan
Yotsuya Internal Medicine Clinic
Shinjuku ku, Tokyo, Japan
Obayashi Clinic
Sumida city, Tokyo, Japan
Sumidagawa Clinic
Sumida ku, Tokyo, Japan
ISHII Medical Clinic
Tachikawa-shi, Tokyo, Japan
Takahashi Ko Minako Clinic
Murayama city, Yamagata pref., Japan
Sakae Clinic
Obanazawa city, Yamagata pref., Japan
Obanazawa City Clinic
Obanazawa city, Yamagata pref., Japan
Okuyama Clinic
Obanazawa city, Yamagata pref., Japan
Honma Clinic
Sakata city, Yamagata pref., Japan
Yamagata Tokushukai Hospital
Yamagata city, Yamagata pref., Japan
Nihei Clinic
Yamagata city, Yamagata pref., Japan
Shimasaki Clinic
Yamagata city, Yamagata pref., Japan
Isoda Clinic
Yamagata city, Yamagata pref., Japan
Iwasaki Naika Iin
Iwakuni city, Yamaguchi pref., Japan
Kuwahara Clinic
Iwakuni city, Yamaguchi pref., Japan
Matsuda Medical Clinic
Shimonoseki city, Yamaguchi pref., Japan
Ayame Medical Clinic
Shimonoseki city, Yamaguchi pref., Japan
Noda Clinic
Shimonoseki city, Yamaguchi pref., Japan
Mizumachi Medical Clinic
Shimonoseki city, Yamaguchi pref., Japan
Johno Clinic
Shimonoseki city, Yamaguchi pref., Japan
Fujii Clinic
Ube City, Yamaguchi pref., Japan
Watada‐naika Hospital
Ube city, Yamaguchi pref., Japan
Shakaiiryouhoujin Onaka Hospital
Ube City, Yamaguchi pref., Japan
Ouchi Clinic
Yamaguchi city, Yamaguchi pref., Japan
Yoshizaki Clinic
Chuo city, Yamanashi pref., Japan
Takahashi Clinic
Nishi Yatsushiro gun, Yamanashi pref., Japan
Higashikatsura Medical Clinic
Tsuru city, Yamanashi pref., Japan
Fukushi Clinic
Aomori city, Japan
Kashiwagi Clinic
Ayase city, Japan
Hayashi Diabetes Clinic
Chigasaki city, Japan
Uchiyama Clinic
Joetsu city, Japan
Nitta Medical Clinic
Kamiinagun, Japan
Imai Clinic
Kawasaki city, Japan
Tani Clinic
Kitakyusyu City, Japan
Marumo Clinic
Koganei city, Japan
Ihara Clinic
Kyoto city, Japan
Goko-Hospital
Matsudo city, Japan
Satou Clinic
Moka city, Japan
Iino Clinic
Nirasaki city, Japan
Miura Clinic
Osaka City, Japan
Kuroda Iin
Otsuki City, Japan
Sasaki Clinic
Sendai city, Japan
Kamata Clinic of Internal Medicine
Shiki city, Japan
Nishikawa Clinic
Shimoda city, Japan
Satou Iin
Shimoinagun, Japan
Kumagai Clinic
Shinshiro city, Japan
Suzuki Clinic
Toyokawa city, Japan
Benibana Clinic
Yamagata city, Japan
Shonan Ochanomizu Clinic
Yokohama city, Japan
Hongo Clinic
Yokohama city, Japan
Tani Clinic Internal Medicine, Allergology & Rheumatology
Yokohama city, Japan
Fujimi Clinic
Yokohama city, Japan
Jiyukai Yamada Naika
Yokohama city, Japan
Sponsors and Collaborators
Positive Trial Group
  More Information

No publications provided

Responsible Party: Hisao Ogawa, Department of Cardiovascular Medicine, Faculty of Graduate School of Medical Sciences, Kumamoto University
ClinicalTrials.gov Identifier: NCT01173939     History of Changes
Other Study ID Numbers: 0035
Study First Received: July 27, 2010
Last Updated: May 30, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Positive Trial Group:
Hypercholesterolemia with concomitant type 2 diabetes and hypertension

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases
Pravastatin
Rosuvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014