Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting (ATTENTION)

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA

The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100089
        • Hospital attached to aeromedicine institute of P.L.A (466 Hospital)
      • Shanghai, China, 200433
        • Shanghai Yangpu District Central Hospital
      • Shanghai, China, 201111
        • Shanghai Minhang District Central Hospital
    • Anhui
      • Fuyang, Anhui, China, 236000
        • First People's Hospital of Fuyang City
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital Capital Medical University
      • Beijing, Beijing, China, 100053
        • Guang'anmen Hospital
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China, 100028
        • China Meitan General Hospital
      • Beijing, Beijing, China, 100048
        • Navy General Hospital
      • Beijing, Beijing, China, 100038
        • Fu Xing Hospital Affiliated to Capital Medical University
      • Beijing, Beijing, China, 102400
        • The First Hospital of Fangshan District , Beijing
      • Beijing, Beijing, China, 102600
        • People's Hospital of Beijing Daxing District
      • Biejing, Beijing, China
        • China Meitan General Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 408000
        • Fuling Center Hospital of Chongqing City
      • Chongqing, Chongqing, China, 400060
        • Chongqing Dianjiang People's Hospital
      • Chongqing, Chongqing, China, 402160
        • Yongchuan Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 404100
        • Chongqing Wanzhou People's Hospital
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Xiamen Cardiovascular Hospital
    • Guangdong
      • Foshan, Guangdong, China, 528300
        • Shunde People's Hospital
      • Guangzhou, Guangdong, China
        • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510580
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Jiangmen, Guangdong, China, 529000
        • Jiangmen Central Hospital
      • Zhuhai, Guangdong, China
        • Zhuhai People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The second Hospital Of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150030
        • Heilongjiang Provincial Hospital
    • Henan
      • Hebi, Henan, China
        • The Peoples Hspital of Hebi City
      • Jiaozuo, Henan, China, 454001
        • Jiaozuo City Second People's Hospital
      • Puyang, Henan, China
        • Puyang Oilfield General Hosipital
      • Zhengzhou, Henan, China
        • The first affiliated hospital of henan university of TCM
      • Zhengzhou, Henan, China, 450000
        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, China
        • Zhengzhou No. 7 People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Wuhan University - Renmin Hospital (Hubei General Hospital)
    • Jiangsu
      • Huaian, Jiangsu, China, 223300
        • Huai'an First People's Hospital
      • Taizhou, Jiangsu, China, 225300
        • Jiangsu Taizhou People's Hospital
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu People's Hospital
    • Jiangsu China
      • Nanjing,, Jiangsu China, China, 211100
        • Jiangning People's Hospital
    • Jiangsu,china
      • Nanjing, Jiangsu,china, China, 210024
        • Cardiology Provincial Hospital of Jiangsu Province
    • Jiangsu，china
      • Nanjing, Jiangsu，china, China, 211102
        • Nanjing colleague hospital
    • Jiangxi
      • NanChang, Jiangxi, China, 330006
        • The 2nd hospital of Nanchang university
    • Liaoning
      • Shenyang, Liaoning, China, 110015
        • The General Hospital of Shenyang Military
    • Nanjing, Jiangsu
      • Nanjing, Nanjing, Jiangsu, China, 210001
        • Nanjing Red Cross Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Ji'nan Central Hospital
      • Qingdao, Shandong, China, 266011
        • The Affiliated Hospital of Qingdao University
    • Shanghai，china
      • Shanghai, Shanghai，china, China, 200082
        • Shanghai University of Traditional Chinese Medicine affiliated Yueyang Hospital of traditional Chine
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Shanxi Cardiovascular Hospital
    • Zhejiang
      • Jinhua, Zhejiang, China, 322100
        • Dongyang People's Hospital
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
      • Ningbo, Zhejiang, China
        • The Affiliated Hospital of Medical College of Ningbo University
      • Quzhou, Zhejiang, China, 324000
        • Quzhou Hospital of Zhejiang University
      • Ruian, Zhejiang, China, 325200
        • Ruian People's Hospital
    • Zhejiang China
      • Hangzhou, Zhejiang China, China, 311200
        • The First People's Hospital of Xiaoshan District
    • Zhejiangchina
      • Lanxi, Zhejiangchina, China, 321100
        • Lanxi Municipal People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese cardiology patients

Description

Inclusion Criteria:

  • Men and women aged ≥18 years;
  • Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
  • Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
  • Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.

Exclusion Criteria:

  • Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
  • Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Atorvastatin dose titration (single-arm)
Judged by investigators, patients in cardiology department who are using atorvastatin can be included into this study, if they are eligible. During the study, the dose can be titrated based on the judgement of investigator
Other: No intervention
Because this is a non-interventional study, there is no intervention here.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
Time Frame: 12 weeks
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.
12 weeks
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level
Time Frame: 12 weeks
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline for Lipid Parameters at Week 12 for Overall
Time Frame: Baseline to Week 12
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported.
Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall
Time Frame: Baseline to Week 12
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.
Baseline to Week 12
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group
Time Frame: Baseline to Week 12
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported.
Baseline to Week 12
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level
Time Frame: Baseline to Week 12
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.
Baseline to Week 12
Study Drug Exposure for Overall - Total Dose and Week 12 Dose
Time Frame: Day 1 to Week 12
Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12
Day 1 to Week 12
Study Drug Exposure for Overall - Daily Dose
Time Frame: Day 1 to Week 12
Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.
Day 1 to Week 12
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose
Time Frame: Day 1 to Week 12
Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Day 1 to Week 12
Study Drug Exposure Within Each CVD Risk Group -Daily Dose
Time Frame: Day 1 to Week 12
Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Day 1 to Week 12
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall
Time Frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.
Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level
Time Frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Number of Participants With Adverse Events of Special Interest (AESI) for Overall
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level
Time Frame: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk
Time Frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- ALT and AST
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase
Time Frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5%~10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%~15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Precentage of Participants With Discontinuation From the Study for Overall
Time Frame: 12 weeks of follow-up
Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.
12 weeks of follow-up
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level
Time Frame: 12 weeks of follow-up
Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
12 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A2581197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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