Acarbose Cardiovascular Evaluation Trial
ACE
A Long-term, Multicentre, Double-blind, Randomised Parallel-group Trial to Determine Whether Reducing Post-prandial Glycaemia Can Reduce Cardiovascular-related Morbidity and Mortality in Patients With Established Coronary Heart Disease or Acute Coronary Syndrome Who Have Impaired Glucose Tolerance
2 other identifiers
interventional
6,526
2 countries
177
Brief Summary
The purpose of this study is to determine whether acarbose therapy can reduce cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance (IGT) who have established coronary heart disease (CHD) or acute coronary syndrome (ACS). A secondary objective of the study is to determine if acarbose therapy can prevent or delay transition to type 2 diabetes mellitus (T2DM) in this patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
Longer than P75 for phase_4
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedStudy Start
First participant enrolled
February 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2017
CompletedJuly 25, 2017
July 1, 2017
8.2 years
January 26, 2009
July 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite cardiovascular outcome defined as the time after randomisation to the first occurrence of any one of the following: -Cardiovascular death -Non-fatal MI -Non-fatal stroke -Hospitalisation for Unstable Angina -Hospitalisation for Heart Failure
Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
Secondary Outcomes (6)
Transition to type 2 diabetes confirmed by two successive diagnostic plasma glucose values (FPG >7.0 mmol/l and/or 2HPG > 11.1 mmol/l), with no intervening non-diagnostic values.
All cause mortality
Each of the components of the primary composite cardiovascular outcome will also be analysed individually, both as first and as total events.
Major Cardiovascular Event (MACE) composite cardiovascular outcome, defined as the time after randomisation to the first occurrence of any one of the following: - Cardiovascular death - Non-fatal MI - Non-fatal stroke
Impaired renal function as evidenced by: A reduced estimate of glomerular filtration rate( eGFR <30 ml/minute/ 1.73 m2) estimated using the Chinese MDRD formula, a doubling of the baseline plasma creatinine level, a halving of the baseline eGFR
- +1 more secondary outcomes
Study Arms (2)
Acarbose
ACTIVE COMPARATORThe participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 150mg/day).
Matching Placebo
PLACEBO COMPARATORThe participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).
Interventions
The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 150mg/day).
The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).
Eligibility Criteria
You may qualify if:
- Male or female, aged 50 years or more.
- Definite CHD, defined as a, b or c below:
- Previous myocardial infarction (MI) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:
- Typical clinical presentation
- Confirmatory ECG changes
- Appropriate elevation of cardiac enzymes/biomarkers
- Previous unstable angina (UA) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:
- Typical clinical presentation
- Confirmatory ECG changes
- Either elevation of a cardiac biomarker or a \>50% stenosis in ≥1 major epicardial coronary artery shown on coronary angiography or CT angiography. Where stenosis is reported in a qualitative manner, the categories "moderate" and "severe" will be taken as equating to \>50% stenosis.
- Current stable angina defined as:
- Typical clinical history with symptoms occurring within the last month, and
- A \>50% stenosis in ≥1 major epicardial coronary artery shown on coronary angiography or CT angiography. Where stenosis is reported in a qualitative manner, the categories "moderate" and "severe" will be taken as equating to \>50% stenosis.
- Impaired glucose tolerance diagnosed on a single standard oral glucose tolerance test (OGTT) , defined as a 2-hour plasma glucose (2HPG) value ≥7.8 but \<11.1 mmol/l and a fasting plasma glucose (FPG) \<7.0 mmol/l within six months prior to enrollment.
- Optimised cardiovascular drug therapy.
- +2 more criteria
You may not qualify if:
- Previous history of diabetes, other than gestational diabetes.
- MI, unstable angina, stroke or a transient ischaemic attack (TIA) within the previous three months.
- Planned or anticipated coronary, cerebrovascular or peripheral arterial revascularisation or other major surgical intervention, at the time of randomisation
- New York Heart Association (NYHA) class III or IV heart failure.
- Evidence of severe hepatic disease.
- Evidence of severe renal impairment or an eGFR \<30 ml/min/1.73m2 (derived using the Modification of Diet in Renal Disease, MDRD, Chinese equation)
- Any other condition likely to reduce adherence to the protocol e.g. alcoholism, major active psychiatric disorder, cognitive impairment or a condition likely to markedly limit life expectancy e.g. malignancy.
- Pregnancy (or planned pregnancy within the next five years).
- Concurrent participation in any other clinical interventional trial. Note: Patients who were treated previously with an alphaglucosidase inhibitor must have at least a three-month washout period before being randomised into the ACE trial.
- Known intolerance to alpha glucosidase inhibitors or gastrointestinal problems.
- Thought by the investigator for any reason to be unsuitable for participation in this clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Bayercollaborator
Study Sites (177)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230032, China
Beijing Chuiyangliu Hospital
Beijing, Beijing Municipality, 100022, China
China Meitan General Hospital
Beijing, Beijing Municipality, 100028, China
Beijing Anzhen Hospital of The Capital University of Medical Sciences
Beijing, Beijing Municipality, 100029, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Ji Shui Tan Hospital
Beijing, Beijing Municipality, 100035, China
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038, China
Fu Xing Hospital
Beijing, Beijing Municipality, 100038, China
Beijing Shijingshan Hospital
Beijing, Beijing Municipality, 100043, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Aerospace Central Hospital
Beijing, Beijing Municipality, 100049, China
Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Wangjing Hospital of CACMS
Beijing, Beijing Municipality, 100053, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Healthy Palace Hospital
Beijing, Beijing Municipality, 100054, China
Aerospace 731 Hospital
Beijing, Beijing Municipality, 100074, China
General Hospital of Second Artillery PLA
Beijing, Beijing Municipality, 100088, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Anzhen Hospital of The Capital University of Medical Sciences 2nd.
Beijing, Beijing Municipality, 101200, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101200, China
Beijing Yanhua Hospital
Beijing, Beijing Municipality, 102500, China
Chongqing Medical University Second Afflicated Hospital
Chongqing, Chongqing Municipality, 400010, China
Chongqing Zhongshan Hospital
Chongqing, Chongqing Municipality, 400013, China
Chongqing Third People's Hospital
Chongqing, Chongqing Municipality, 400014, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Da Ping Hospital
Chongqing, Chongqing Municipality, 400042, China
The Second People's Hospital of Chongqing
Chongqing, Chongqing Municipality, 402160, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, 350001, China
The People's Hospital of Fujian Province
Fuzhou, Fujian, 350004, China
The First Hospital of Xiamen
Xiamen, Fujian, 361003, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
The Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510150, China
Wu Jing Zhong Dui Hospital of Guangdong Province
Guangzhou, Guangdong, 510507, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Zhong Shan City People's Hospital
Zhongshan, Guangdong, 528403, China
The Fifth Affiliated Hospital of Sun Yat-Sen University
Zhuhai, Guangdong, 519000, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545005, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Minzu Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530001, China
303 Hospital of People's Liberation Army
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, 550004, China
Cangzhou Central Hospital
Cangzhou, Hebei, 062650, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
Bethune International Peace Hospital
Shijiazhuang, Hebei, 050082, China
Tangshan Workers Hospital
Tangshan, Hebei, 063000, China
The Affiliated Hospital of North China Coal Medical University
Tangshan, Hebei, 063000, China
Yu Tian County Hospital
Tangshan, Hebei, 064100, China
The Third Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 075000, China
Da Qing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan, 471003, China
Luo Yang Central Hospital, Affiliated to Zhengzhou University
Luoyang, Henan, 471009, China
The First Affiliated Hospital of Henan College of TCM
Zhengzhou, Henan, 450000, China
The People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
Union Hospital of Tongji Medical College of Huazhong
Wuhan, Hubei, 430022, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College of Huazhong
Wuhan, Hubei, 430030, China
Pu'ai Hospital of Wuhan City
Wuhan, Hubei, 430033, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
The Fourth Hospital of Changsha
Changsha, Hunan, 410006, China
Xiangya Hospital Central-South University
Changsha, Hunan, 410008, China
The Third Hospital of Changsha
Changsha, Hunan, 410015, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014040, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000, China
Inner Mongolia Hospital
Hohhot, Inner Mongolia, 010017, China
81st Hospital of Chinese PLA
Nanjing, Jiangsu, 210002, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Nanjing Zhongda Hospital
Nanjing, Jiangsu, 210009, China
BENQ Hospital
Nanjing, Jiangsu, 210017, China
Jiangsu Province Official Hospital
Nanjing, Jiangsu, 210024, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Jiangsu Provincial Hospital of TCM
Nanjing, Jiangsu, 210029, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Wuxi No.3 People's Hospital
Wuxi, Jiangsu, 214041, China
Hospital Affiliated Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The Second Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
Zhenjiang First People's Hospital
Zhenjiang, Jiangsu, 212002, China
Jiujiang University Hospital
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
The Central Hospital of Anshan
Anshan, Liaoning, 114001, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
The First Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Dalian Central Hospital
Dalian, Liaoning, 116033, China
Xianyang Central Hospital
Shengyang, Liaoning, 712000, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110021, China
The Fourth Hospital of China Medical University
Shenyang, Liaoning, 110032, China
The First Hospital of Yinchuan
Yinchuan, Ningxia, 750001, China
Affiliated Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
The People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750021, China
Xi'an Central Hospital
Xi'an, Shaanxi, 710003, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Affiliated Hospital of Xi'an Medical college
Xi'an, Shaanxi, 710077, China
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, 716000, China
Yan'an People's Hospital
Yan’an, Shaanxi, 716000, China
The First Hospital of Yulin
Yulin, Shaanxi, 719000, China
The Central Hospital of Jinan
Jinan, Shandong, 250013, China
The First People's Hospital of Jinan
Jinan, Shandong, 250013, China
The General Hospital of Jinan Military Region
Jinan, Shandong, 250031, China
Linyi People's Hospital
Linyi, Shandong, 276003, China
Hospital Affiliated of Medical School, Qingdao University
Qingdao, Shandong, 266003, China
The Qingdao Municiple Hospital
Qingdao, Shandong, 266011, China
Qingdao Fuwai Hospital
Shibei, Shandong, 266034, China
Taian City Central Hospital
Taian, Shandong, 271000, China
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011, China
Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School
Shanghai, Shanghai Municipality, 200025, China
Shanghai Central Hospital of Xuhui District
Shanghai, Shanghai Municipality, 200031, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai Huadong Hospital
Shanghai, Shanghai Municipality, 200040, China
Shanghai Putuo District People's Hospital
Shanghai, Shanghai Municipality, 200060, China
Putuo District Center Hospital
Shanghai, Shanghai Municipality, 200062, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Number 411 Hospital of PLA
Shanghai, Shanghai Municipality, 200081, China
Shanghai Central Hospital of Yangpu District
Shanghai, Shanghai Municipality, 200090, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
Renji Hospital Affilicated to Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, 200135, China
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanghai Zhabei District Shibei Hospital
Shanghai, Shanghai Municipality, 200435, China
Shanghai Jinshan Hospital
Shanghai, Shanghai Municipality, 200540, China
Shanghai Pudong New District People's Hospital
Shanghai, Shanghai Municipality, 201200, China
General Hospital of Tisco
Taiyuan, Shanxi, 030003, China
The Third Engineering Bureau Hospital of Ministry of Railway
Taiyuan, Shanxi, 030006, China
Taiyuan City Central Hospital
Taiyuan, Shanxi, 030009, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024, China
PLA No.323 Hospital
Xi’an, Shanxi, 710054, China
Chengdu First People's Hospital
Chengdu, Sichuan, 610016, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610041, China
The West China Hospital
Chengdu, Sichuan, 610041, China
Sichuan Mianyang 404 Hospital
Sichuan, Sichuan, 621000, China
Tianjin Union Hospital
Tianjin, Tianjin Municipality, 300050, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051, China
Tianjin Union Medicine Centre
Tianjin, Tianjin Municipality, 300121, China
Army Police's Medical College Affiliated Hospital
Tianjin, Tianjin Municipality, 300162, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170, China
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, 300192, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Dagang Oil-Field General Hospital
Tianjin, Tianjin Municipality, 300280, China
The Fifth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300450, China
First Affiliated Hospital of the Medical College
Shihezi, Xinjiang, 832008, China
Xin Jiang Traditional Chinese Medicine Hospital
Ürümqi, Xinjiang, 830000, China
General Hospital of Xinjiang Production and Construction Corps
Ürümqi, Xinjiang, 830002, China
The 474th Hospital of PLA
Ürümqi, Xinjiang, 830013, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650032, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650101, China
People's Hospital of Yuxi City
Yuxi, Yunnan, 653100, China
Zhe Jiang Hospital
Hangzhou, Zhejiang, 310013, China
Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University
Hangzhou, Zhejiang, 310016, China
Prince of Wales Hospital
Hong Kong, Hong Kong
Related Publications (3)
Wamil M, McMurray JJV, Scott CAB, Coleman RL, Sun Y, Standl E, Ryden L, Holman RR. Predicting heart failure events in patients with coronary heart disease and impaired glucose tolerance: Insights from the Acarbose Cardiovascular Evaluation (ACE) trial. Diabetes Res Clin Pract. 2020 Dec;170:108488. doi: 10.1016/j.diabres.2020.108488. Epub 2020 Oct 6.
PMID: 33035598DERIVEDGerstein HC, Coleman RL, Scott CAB, Xu S, Tuomilehto J, Ryden L, Holman RR; ACE Study Group. Impact of Acarbose on Incident Diabetes and Regression to Normoglycemia in People With Coronary Heart Disease and Impaired Glucose Tolerance: Insights From the ACE Trial. Diabetes Care. 2020 Sep;43(9):2242-2247. doi: 10.2337/dc19-2046. Epub 2020 Jul 8.
PMID: 32641379DERIVEDHolman RR, Coleman RL, Chan JCN, Chiasson JL, Feng H, Ge J, Gerstein HC, Gray R, Huo Y, Lang Z, McMurray JJ, Ryden L, Schroder S, Sun Y, Theodorakis MJ, Tendera M, Tucker L, Tuomilehto J, Wei Y, Yang W, Wang D, Hu D, Pan C; ACE Study Group. Effects of acarbose on cardiovascular and diabetes outcomes in patients with coronary heart disease and impaired glucose tolerance (ACE): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):877-886. doi: 10.1016/S2213-8587(17)30309-1. Epub 2017 Sep 13.
PMID: 28917545DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor Rury R Holman, FRCP FMedSci
Diabetes Trials Unit, University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 27, 2009
Study Start
February 17, 2009
Primary Completion
April 11, 2017
Study Completion
April 18, 2017
Last Updated
July 25, 2017
Record last verified: 2017-07