Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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NCT01107743

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians

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


Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets
before.

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Hypertension, Angina Pectoris, Hypercholesterolemia, Familial HypercholesterolemiaAmlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01107743
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Brief Summary In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin (Caduet® Combination Tablets) in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
Detailed Description All the subjects whom an investigator prescribes the first Amlodipine /Atorvastatin (Caduet®) Combination Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.
Condition
  • Hypertension
  • Angina Pectoris
  • Hypercholesterolemia
  • Familial Hypercholesterolemia
Intervention Drug: Amlodipine/Atorvastatin

Amlodipine and Atorvastatin combination Tablet is indicated in following subjects for whom treatment with both amlodipine and atorvastatin is appropriate.

Subjects with concurrent hypertension or angina pectoris and hypercholesterolemia or familial hypercholesterolemia Indications for amlodipine and atorvastatin.

For oral use, amlodipine and atorvastatin combination tablet is given once daily. Dosage must be individualized based on dosage and administration for each individual component.

Amlodipine

  • Hypertension Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose.
  • Angina pectoris For oral use, the usual adult dosage is 5 mg of amlodipine once daily. Atorvastatin
  • Hypercholesterolemia For oral use, the usual adult dosage is 10-20 mg of atorvastatin once daily.
  • Familial hypercholesterolemia For oral use, the usual adult dosage is 10-40 mg of atorvastatin once daily.
Other Name: Caduet
Study Groups/Cohorts Amlodipine and Atorvastatin Combination Tablet
Subjects taking Amlodipine and Atorvastatin Combination Tablets
Intervention: Drug: Amlodipine/Atorvastatin
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 Status Completed
Actual Enrollment
 (submitted: May 15, 2012)		1291
Original Estimated Enrollment
 (submitted: April 20, 2010)		1200
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians

Exclusion Criteria:

Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.

Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01107743
Other Study ID Numbers A3841063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2013