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:
Positive Trial Group
Information provided by:
Positive Trial Group
ClinicalTrials.gov Identifier:
NCT01173939
First received: July 27, 2010
Last updated: May 30, 2011
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Angina
Cholesterol
Diabetes
Diabetes Type 2
Heart Attack
High Blood Pressure
Statins
Transient Ischemic Attack
U.S. FDA Resources
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:
- Patients giving voluntary written consent to participate in the study
- Male or female patients 50 years of age or older (at informed consent)
- Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
- Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
- Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)
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:
- Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
- Patients judged to have familial hypercholesterolemia
- Patients with a serum triglyceride level of ≥400 mg/dL
- Patients with a history of myocardial infarction
- Patients with a history of coronary revascularization (PCI or CABG)
- Patients with a history of treatment of unstable angina
- Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
- Heart failure patients
- Patients with a history of hypersensitivity to statins
- Patients with a history of drug-induced myopathy
- Patients with poorly controlled arrhythmia
- Patients with severe liver or kidney disease
- Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
- Patients who are or may be pregnant
- Patients judged by the investigators to be ineligible for participation in the study for any other reason
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173939
Hide Study Locations
Hide Study LocationsLocations
| 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 May 23, 2013