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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01107743
First received: April 20, 2010
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Angina Pectoris
Hypercholesterolemia
Familial Hypercholesterolemia
 Drug: Amlodipine/Atorvastatin
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The frequency of treatment related adverse events. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of responders to Amlodipine/Atorvastatin treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Risk factors likely to affect the proportion of responders. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 1291
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Amlodipine and Atorvastatin Combination Tablet
Subjects taking Amlodipine and Atorvastatin Combination Tablets
 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107743

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01107743     History of Changes
Other Study ID Numbers: A3841063
Study First Received: April 20, 2010
Last Updated: May 15, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Hypertension
Angina pectoris
Hypercholesterolemia
Familial hypercholesterolemia
 Japanese
caduet
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Angina Pectoris
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hypertension
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013