HypertensionNCT01107743
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
An observational study of Hypertension and Angina Pectoris, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Angina Pectoris, Hypercholesterolemia
- What is being tested?
- Amlodipine/Atorvastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,291 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.
Who may be able to join
- Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians
Who cannot join
- Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.
About this study
Official title: Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
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.
Read the 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.
- Being tested
- Amlodipine/Atorvastatin
- Keywords
- Hypertension, Angina pectoris, Hypercholesterolemia, Familial hypercholesterolemia, Japanese, caduet, Regulatory Post Marketing Commitment Plan
- Medical subject headings
- Hypertension, Angina Pectoris, Hypercholesterolemia, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/AtorvastatinDrug
Also called Caduet
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.
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Subjects taking Amlodipine and Atorvastatin Combination Tablets Receives: Drug: Amlodipine/Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (34)
Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
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). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 years is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, "ClassⅠ, ClassⅡ, or ClassⅢ" is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension).
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, "Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ" is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.
Measured: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, "ClassⅠ, ClassⅡ, or ClassⅢ" is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension).
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, "Class1, Class2, Class3, or Class4" is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Measured: 8 weeks
Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, "Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ" is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Measured: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107743
- Sponsor's protocol ID
- A3841063
- Status last verified
- Jan 2021
- First submitted
- 20 Apr 2010
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- ClinicalTrials.gov ID
- NCT01107743
- Acronym / sponsor ID
- A3841063
- Keywords
- Hypertension, Angina pectoris, Hypercholesterolemia, Familial hypercholesterolemia, Japanese, caduet, Regulatory Post Marketing Commitment Plan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,291 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 30 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | – | Drug: Amlodipine/AtorvastatinSubjects taking Amlodipine and Atorvastatin Combination Tablets |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.
Key inclusion criteria (1 listed)
- Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians
Key exclusion criteria (1 listed)
- Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine/AtorvastatinAlso: CaduetAmlodipine 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. | Drug | Amlodipine and Atorvastatin Combination Tablet |
Primary outcome
Number of Treatment Related Adverse Events.
Time frame: 8 weeks
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.
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
Time frame: 8 weeks
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.
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
Time frame: 8 weeks
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.
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
Time frame: 8 weeks
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.
34 secondary outcomes
Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
Time frame: 8 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Gender.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Age.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Complications.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
Time frame: 8 weeks
Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
Time frame: 8 weeks
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Angina Pectoris, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Related Adverse Events. (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.