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

NCT01107743 | Completed Results

• 1 other identifier: A3841063
• Study Type: observational
• Target: 1,291
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Angina Pectoris; Hypercholesterolemia; Familial Hypercholesterolemia

Keywords

Hypertension; Angina pectoris; Hypercholesterolemia; Familial hypercholesterolemia; Japanese; caduet; Regulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (4)

• Number of Treatment Related Adverse Events.

  Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.

  8 weeks

• Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.

  The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.

  8 weeks

• Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.

  The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.

  8 weeks

• Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.

  The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.

  8 weeks

Secondary Outcomes (34)

• Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.

  8 weeks

• Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.

  8 weeks

• Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.

  8 weeks

• Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.

  8 weeks

• Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.

  8 weeks

Study Arms (1)

Amlodipine and Atorvastatin Combination Tablet

Subjects taking Amlodipine and Atorvastatin Combination Tablets

Drug: Amlodipine/Atorvastatin

Interventions

Amlodipine/Atorvastatin DRUG

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.

Also known as: Caduet

Amlodipine and Atorvastatin Combination Tablet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension; Angina Pectoris; Hypercholesterolemia; Hyperlipoproteinemia Type II

Interventions

amlodipine, atorvastatin drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 21, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: May 30, 2013

Record last verified: 2021-01