Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF
NCT ID: NCT02007720
Last Updated: 2019-08-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
876 participants
INTERVENTIONAL
2014-03-12
2017-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.
Placebo
Intravenous infusion
Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Serelaxin
Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.
Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Serelaxin
Intravenous infusion
Interventions
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Placebo
Intravenous infusion
Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Serelaxin
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening:
* Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization
* Pulmonary congestion on chest radiograph
* Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL
* Systolic BP ≥125 mmHg at the start and at the end of screening
* Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
* Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
* Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).
Exclusion Criteria
* Temperature \>38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
\*Patients with systolic blood pressure \>180 mmHg at the end of screening
* AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \<45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of \>130 beats per minute
* Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin \> 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).
\*Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm2 or mean gradient \>50 mmHg on prior or current echocardiogram), and severe mitral stenosis
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Lanzhou, Gansu, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Suzhou, Jiangsu, China
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Yangzhou, Jiangsu, China
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Shenyang, Liaoning, China
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Shenyang, Liaoning, China
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Shanghai, Shanghai Municipality, China
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Zhujing, Shanghai Municipality, China
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Xian, Shanxi, China
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Tianjin, Tianjin Municipality, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, , China
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Chongqing, , China
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Shanghai, , China
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Ahmedabad, Gujarat, India
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Vadodara, Gujarat, India
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Rajasthan, India, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Chennai, Tamil Nadu, India
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Hyderabad, Telangana, India
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Nagakute, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Kamogawa, Chiba, Japan
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Saijō, Ehime, Japan
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Chikushino-shi, Fukuka, Japan
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Iizuka, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Ōgaki, Gifu, Japan
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Kushiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Amagasaki, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Mito, Ibaraki, Japan
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Kanazawa, Ishikawa-ken, Japan
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Kan’onjichō, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Yatsushiro, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Uji, Kyoto, Japan
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Sendai, Miyagi, Japan
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Nakano, Nagano, Japan
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Saku, Nagano, Japan
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Ueda, Nagano, Japan
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Niigata, Niigata, Japan
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Osaka, Osaka, Japan
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Kawaguchi, Saitama, Japan
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Sayama, Saitama, Japan
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Wako, Saitama, Japan
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Kusatsu, Shiga, Japan
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Hamamatsu, Shizuoka, Japan
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Kakegawa, Shizuoka, Japan
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Akishima, Tokyo, Japan
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Chuo Ku, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Musashino, Tokyo, Japan
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Shinagawa Ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Tanabe, Wakayama, Japan
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Osaka, , Japan
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Saitama, , Japan
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Amman, JOR, Jordan
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Amman, , Jordan
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Amman, , Jordan
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Beirut, , Lebanon
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Beirut, , Lebanon
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El Achrafiyé, , Lebanon
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Hazmiyeh, , Lebanon
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Kuala Lumpur, MYS, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Kuching, Sarawak, Malaysia
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Kuala Lumpur, Selangor, Malaysia
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Sungai Buloh, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Quezon City, Manila, Philippines
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Manila, National Capital Region, Philippines
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Makati City, , Philippines
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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San Juan City, , Philippines
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Singapore, , Singapore
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Singapore, , Singapore
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Gyeonggi-do, Bucheon Si, South Korea
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Wŏnju, Gangwon-do, South Korea
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Bundang Gu, Gyeonggi-do, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Cheongju-si, North Chungcheong, South Korea
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Seoul, Seocho Gu, South Korea
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Busan, , South Korea
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Gwangju, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yilan, , Taiwan
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Songkhla, Hat Yai, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Muang, , Thailand
Countries
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References
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Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CRLX030A2302
Identifier Type: -
Identifier Source: org_study_id
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