Trial · NCT01107743
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01107743, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-05-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan). Trials, record NCT01107743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01107743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT01107743
- Status
- Completed
- Enrollment
- 1,291 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
- Interventions
- Amlodipine/Atorvastatin
- First posted
- 2010-04-21
- Last updated
- 2021-01-28
- Results first posted
- 2013-05-30
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Related Adverse Events. | 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. |
| Primary | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. | 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. |
| Primary | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. | 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. |
| Primary | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. | 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. |
| Secondary | Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | 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). 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | 8 weeks | Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | 8 weeks | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | 8 weeks | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 8 weeks | 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). |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. | 8 weeks | 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. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Related Adverse Events. | 8 weeks | The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| PRIMARY | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. | 8 weeks | The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| PRIMARY | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. | 8 weeks | The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| PRIMARY | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. | 8 weeks | The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
| SECONDARY | Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | 8 weeks | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | 8 weeks | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | 8 weeks | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | 8 weeks | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 8 weeks | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. | 8 weeks | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Related Adverse Events. | Amlodipine and Atorvastatin Combination Tablet | 18 | participants | ||
| Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. | Amlodipine and Atorvastatin Combination Tablet | 1151 | participants | ||
| Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. | Amlodipine and Atorvastatin Combination Tablet | 163 | participants | ||
| Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. | Amlodipine and Atorvastatin Combination Tablet | 1034 | participants | ||
| Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | Amlodipine and Atorvastatin Combination Tablet | Anaemia | 1 | participants | |
| Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | Amlodipine and Atorvastatin Combination Tablet | Hypoproteinaemia | 1 | participants | |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | Male | 7 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | Female | 11 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | <65 Years | 5 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | >=65 Years | 13 | participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine and Atorvastatin Combination Tablet | 1,291 | |
| Overall Study | COMPLETED | Amlodipine and Atorvastatin Combination Tablet | 1,245 | |
| Overall Study | NOT COMPLETED | Amlodipine and Atorvastatin Combination Tablet | 46 |
Source ClinicalTrials.gov
Adverse events19
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoproteinaemia | Metabolism and nutrition disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Dizziness | Nervous system disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Eyelid oedema | Eye disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Orthostatic hypotension | Vascular disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Flushing | Vascular disorders | Amlodipine and Atorvastatin Combination Tablet | 2 | 1,245 | 2 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Gingival swelling | Gastrointestinal disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Constipation | Gastrointestinal disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Hepatic function abnormal | Hepatobiliary disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
| other | Liver disorder | Hepatobiliary disorders | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine and Atorvastatin Combination Tablet | ||
| Total, other adverse events | Amlodipine and Atorvastatin Combination Tablet | 17 | 1,245 |
| Total, serious adverse events | Amlodipine and Atorvastatin Combination Tablet | 1 | 1,245 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons28
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Without Complications vs With Complications: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications. | Trial comparisons |
| Without Concomitant Drugs vs With Concomitant Drugs: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. | Trial comparisons |
| Without Concomitant Drugs vs With Concomitant Drugs: Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs. | Trial comparisons |
| <65 Years vs >=65 Years: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age. | Trial comparisons |
| Without Complications vs With Complications: Risk Factors for the Proportion of Responders for Angina Pectoris -Complications. | Trial comparisons |
| <65 Years vs >=65 Years: Risk Factors for the Proportion of Responders for Angina Pectoris -Age. | Trial comparisons |
| Without Renal Dysfunction vs With Renal Dysfunction: Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction. | Trial comparisons |
| Male vs Female: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | Trial comparisons |
| Without Hepatic Dysfunction vs With Hepatic Dysfunction: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction. | Trial comparisons |
| Without Hypertension vs With Hypertension: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | Trial comparisons |
1 to 10 of 28
See all 28 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01107743
GET https://conductscience.org/api/trials/v1/NCT01107743/registered?page=2