You are here

Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

Last updated on October 16, 2019

FOR MORE INFORMATION
Study Location
First People's Hospital of Fuyang City
Fuyang, Anhui, 236000 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia Coronary Artery Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02565615
Pfizer
Completed
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief TitleAtorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
Official TitleATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA
Brief SummaryThe study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD?
Detailed DescriptionNot Provided
Study TypeObservational [Patient Registry]
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration12 Weeks
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationChinese cardiology patients
ConditionCoronary Artery Disease, Hypercholesterolemia, Hypertension
InterventionOther: No intervention
Because this is a non-interventional study, there is no intervention here.
Study Groups/CohortsAtorvastatin 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
Intervention: Other: No intervention
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: January 11, 2019)
5115
Original Estimated Enrollment
 (submitted: September 29, 2015)
15000
Actual Study Completion DateAugust 2018
Actual Primary Completion DateAugust 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesChina
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02565615
Other Study ID NumbersA2581197
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement
Plan to Share IPD:No
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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now