Acarbose Cardiovascular Evaluation Trial (ACE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00829660
First received: January 26, 2009
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Coronary Heart Disease
Acute Coronary Syndrome
Impaired Glucose Tolerance
Type 2 Diabetes Mellitus (T2DM)
Drug: Acarbose
Drug: Matching Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • A composite cardiovascular outcome defined as the time to first occurrence of any one of the following:; - Cardiovascular death - Non-fatal MI - Non-fatal stroke - Hospitalisation for Unstable Angina - Hospitalisation for Heart Failure [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transition to type 2 diabetes [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Major Cardiovascular Event (MACE) composite cardiovascular outcome, defined as the time to first occurrence of any one of the following: - Cardiovascular death - Non-fatal MI - Non-fatal stroke [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Evidence of NAFLD [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Impaired renal function [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Resource use, costs and cost effectiveness [ Time Frame: Follow-up until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]

Enrollment: 6526
Study Start Date: February 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acarbose
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).
Drug: Acarbose
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).
Other Name: Glucobay
Placebo Comparator: Matching Placebo
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).
Drug: Matching Placebo
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).

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 50 years or more.
  • Definite CHD, defined as a, b or c below:

    1. Previous myocardial infarction (MI) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following (Note: Patients with stents are eligible):

      • Typical clinical presentation
      • Confirmatory ECG changes
      • Appropriate elevation of cardiac enzymes/biomarkers
    2. 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.
    3. 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 75g anhydrous glucose 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.
  • At least 80% adherent to single blind placebo Study Medication during the run-in period.
  • Provision of written informed consent.

Exclusion Criteria:

  • 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.
  • 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 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.
  • 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.
  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: NCT00829660

  Hide Study Locations
Locations
China, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230032
China, Beijing
Beijing Chuiyangliu Hospital
Beijing, Beijing, China, 100022
China Meitan General Hospital
Beijing, Beijing, China, 100028
Beijing Anzhen Hospital of The Capital University of Medical Sciences
Beijing, Beijing, China, 100029
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
Peking University First Hospital
Beijing, Beijing, China, 100034
Beijing Ji Shui Tan Hospital
Beijing, Beijing, China, 100035
Beijing Shijitan Hospital
Beijing, Beijing, China, 100038
Fu Xing Hospital
Beijing, Beijing, China, 100038
Beijing Shijingshan Hospital
Beijing, Beijing, China, 100043
Peking University People's Hospital
Beijing, Beijing, China, 100044
Aerospace Central Hospital
Beijing, Beijing, China, 100049
Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Wangjing Hospital of CACMS
Beijing, Beijing, China, 100053
Xuanwu Hospital Capital Medical University
Beijing, Beijing, China, 100053
Beijing Healthy Palace Hospital
Beijing, Beijing, China, 100054
Aerospace 731 Hospital
Beijing, Beijing, China, 100074
General Hospital of Second Artillery PLA
Beijing, Beijing, China, 100088
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
PLA General Hospital
Beijing, Beijing, China, 100853
Anzhen Hospital of The Capital University of Medical Sciences 2nd.
Beijing, Beijing, China, 101200
Beijing Pinggu Hospital
Beijing, Beijing, China, 101200
Beijing Yanhua Hospital
Beijing, Beijing, China, 102500
China, Chongqing
Chongqing Medical University Second Afflicated Hospital
Chongqing, Chongqing, China, 400010
Chongqing Zhongshan Hospital
Chongqing, Chongqing, China, 400013
Chongqing Third People's Hospital
Chongqing, Chongqing, China, 400014
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Da Ping Hospital
Chongqing, Chongqing, China, 400042
The Second People's Hospital of Chongqing
Chongqing, Chongqing, China, 402160
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China, 350001
The People's Hospital of Fujian Province
Fuzhou, Fujian, China, 350004
The First Hospital of Xiamen
Xiamen, Fujian, China, 361003
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
The Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510150
Wu Jing Zhong Dui Hospital of Guangdong Province
Guangzhou, Guangdong, China, 510507
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510630
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Zhong Shan City People's Hospital
Zhongshan, Guangdong, China, 528403
The Fifth Affiliated Hospital of Sun Yat-Sen University
Zhuhai, Guangdong, China, 519000
China, Guangxi
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China, 545005
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545006
Minzu Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530001
303 Hospital of People's Liberation Army
Nanning, Guangxi, China, 530021
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
China, Guizhou
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, China, 550004
China, Hebei
Cangzhou Central Hospital
Cangzhou, Hebei, China, 062650
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Bethune International Peace Hospital
Shijiazhuang, Hebei, China, 050082
Tangshan Workers Hospital
Tangshan, Hebei, China, 063000
The Affiliated Hospital of North China Coal Medical University
Tangshan, Hebei, China, 063000
Yu Tian County Hospital
Tangshan, Hebei, China, 064100
The Third Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China, 075000
China, Heilongjiang
Da Qing Oilfield General Hospital
Da Qing, Heilongjiang, China, 163001
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
China, Henan
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan, China, 471003
Luo Yang Central Hospital, Affiliated to Zhengzhou University
Luoyang, Henan, China, 471009
The First Affiliated Hospital of Henan College of TCM
Zhengzhou, Henan, China, 450000
The People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450003
The Second Affiliated Hospital of Zhengzhou University
ZhengZhou, Henan, China, 450014
China, Hubei
Union Hospital of Tongji Medical College of Huazhong
Wuhan, Hubei, China, 430022
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Tongji Hospital of Tongji Medical College of Huazhong
Wuhan, Hubei, China, 430030
Pu'ai Hospital of Wuhan City
Wuhan, Hubei, China, 430033
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
China, Hunan
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
The Fourth Hospital of Changsha
Changsha, Hunan, China, 410006
Xiangya Hospital Central-South University
Changsha, Hunan, China, 410008
The Third Hospital of Changsha
Changsha, Hunan, China, 410015
China, Inner Mongolia
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China, 014010
Baotou Central Hospital
Baotou, Inner Mongolia, China, 014040
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China, 024000
Inner Mongolia Hospital
Hohhot, Inner Mongolia, China, 010017
China, Jiangsu
81st Hospital of Chinese PLA
NanJing, Jiangsu, China, 210002
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Nanjing Zhongda Hospital
Nanjing, Jiangsu, China, 210009
BENQ Hospital
Nanjing, Jiangsu, China, 210017
Jiangsu Province Official Hospital
NanJing, Jiangsu, China, 210024
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Jiangsu Provincial Hospital of TCM
NanJing, Jiangsu, China, 210029
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China, 211100
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China, 214002
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Wuxi No.3 People's Hospital
Wuxi, Jiangsu, China, 214041
Hospital Affiliated Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
The Second Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Zhenjiang First People's Hospital
Zhenjiang, Jiangsu, China, 212002
China, Jiangxi
Jiujiang University Hospital
Jiujiang, Jiangxi, China, 332000
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
The Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330008
China, Jilin
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 130033
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
China, Liaoning
The Central Hospital of Anshan
Anshan, Liaoning, China, 114001
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
The First Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
Dalian Central Hospital
Dalian, Liaoning, China, 116033
Xianyang Central Hospital
Shengyang, Liaoning, China, 712000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China, 110016
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110021
The Fourth Hospital of China Medical University
Shenyang, Liaoning, China, 110032
China, Ningxia
The First Hospital of Yinchuan
Yinchuan, Ningxia, China, 750001
Affiliated Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
The People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China, 750021
China, Shaanxi
Xi'an Central Hospital
Xi'an, Shaanxi, China, 710003
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Affiliated Hospital of Xi'an Medical college
Xi'an, Shaanxi, China, 710077
Affiliated Hospital of Yan'an University
Yan'an, Shaanxi, China, 716000
Yan'an People's Hospital
Yanan, Shaanxi, China, 716000
The First Hospital of Yulin
Yulin, Shaanxi, China, 719000
China, Shandong
The Central Hospital of Jinan
Jinan, Shandong, China, 250013
The First People's Hospital of Jinan
Jinan, Shandong, China, 250013
The General Hospital of Jinan Military Region
Jinan, Shandong, China, 250031
Linyi People's Hospital
Linyi, Shandong, China, 276003
Hospital Affiliated of Medical School, Qingdao University
Qingdao, Shandong, China, 266003
The Qingdao Municiple Hospital
Qingdao, Shandong, China, 266011
Qingdao Fuwai Hospital
Shibei, Shandong, China, 266034
Taian City Central Hospital
Taian, Shandong, China, 271000
China, Shanghai
Shanghai Ninth People's Hospital
Shanghai, Shanghai, China, 200011
Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School
Shanghai, Shanghai, China, 200025
Shanghai Central Hospital of Xuhui District
Shanghai, Shanghai, China, 200031
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Shanghai Huadong Hospital
Shanghai, Shanghai, China, 200040
Shanghai Putuo District People's Hospital
Shanghai, Shanghai, China, 200060
Putuo District Center Hospital
Shanghai, Shanghai, China, 200062
Tongji Hospital of Tongji University
Shanghai, Shanghai, China, 200065
Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Number 411 Hospital of PLA
Shanghai, Shanghai, China, 200081
Shanghai Central Hospital of Yangpu District
Shanghai, Shanghai, China, 200090
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200092
Shanghai East Hospital
Shanghai, Shanghai, China, 200120
Renji Hospital Affilicated to Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200127
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai, China, 200135
Changhai Hospital
Shanghai, Shanghai, China, 200433
Shanghai Zhabei District Shibei Hospital
Shanghai, Shanghai, China, 200435
Shanghai Jinshan Hospital
Shanghai, Shanghai, China, 200540
Shanghai Pudong New District People's Hospital
Shanghai, Shanghai, China, 201200
China, Shanxi
General Hospital of Tisco
Taiyuan, Shanxi, China, 030003
The Third Engineering Bureau Hospital of Ministry of Railway
Taiyuan, Shanxi, China, 030006
Taiyuan City Central Hospital
Taiyuan, Shanxi, China, 030009
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 030024
PLA No.323 Hospital
Xi'an, Shanxi, China, 710054
China, Sichuan
Chengdu First People's Hospital
Chengdu, Sichuan, China, 610016
Chengdu Second People's Hospital
Chengdu, Sichuan, China, 610017
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610041
The West China Hospital
Chengdu, Sichuan, China, 610041
Sichuan Mianyang 404 Hospital
Sichuan, Sichuan, China, 621000
China, Tianjin
Tianjin Union Hospital
Tianjin, Tianjin, China, 300050
Tianjin Chest Hospital
Tianjin, Tianjin, China, 300051
Tianjin Union Medicine Centre
Tianjin, Tianjin, China, 300121
Army Police's Medical College Affiliated Hospital
Tianjin, Tianjin, China, 300162
Tianjin Third Central Hospital
Tianjin, Tianjin, China, 300170
Tianjin First Center Hospital
Tianjin, Tianjin, China, 300192
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin, China, 300211
Dagang Oil-Field General Hospital
Tianjin, Tianjin, China, 300280
The Fifth Central Hospital of Tianjin
Tianjin, Tianjin, China, 300450
China, Xinjiang
First Affiliated Hospital of the Medical College
Shihezi, Xinjiang, China, 832008
Xin Jiang Traditional Chinese Medicine Hospital
Urumqi, Xinjiang, China, 830000
General Hospital of Xinjiang Production and Construction Corps
Urumqi, Xinjiang, China, 830002
The 474th Hospital of PLA
Urumqi, Xinjiang, China, 830013
The First Teaching Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
China, Yunnan
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China, 650032
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650032
The Second Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China, 650101
People's Hospital of Yuxi City
Yuxi, Yunnan, China, 653100
China, Zhejiang
Zhe Jiang Hospital
Hangzhou, Zhejiang, China, 310013
Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University
Hangzhou, Zhejiang, China, 310016
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
University of Oxford
Bayer
Investigators
Principal Investigator: Professor Rury R Holman, FRCP FMedSci Diabetes Trials Unit, University of Oxford
  More Information

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00829660     History of Changes
Other Study ID Numbers: 11232  ISRCTN91899513 
Study First Received: January 26, 2009
Last Updated: March 7, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Oxford:
Acarbose

Additional relevant MeSH terms:
Syndrome
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Glucose Intolerance
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Hyperglycemia
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016