Amlodipine 10mg Drug Use Investigation

NCT01252563 | Completed Results

• 1 other identifier: A0531097
• Study Type: observational
• Target: 14,141
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.

Conditions

Hypertension

Keywords

ENTER10; Hypertension; Japanese; Norvasc 10mg; Post Marketing surveillance

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  Last day of observation period (average of 14.76 weeks)

• The Achievement Rate to Ambulatory Blood Pressure Goal

  The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

  4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

• Changes in Ambulatory Systolic Blood Pressure From Baseline

  Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

  4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

• Changes in Ambulatory Diastolic Blood Pressure From Baseline

  Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.

  4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Secondary Outcomes (16)

• Number of Participants With Adverse Events Listed in Japanese Package Insert

  Last day of observation period (average of 14.76 weeks)

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

  Last day of observation period (average of 14.76 weeks)

• Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)

  Last day of observation period (average of 14.76 weeks)

• Number of Participants With Treatment-Related Adverse Events: Male vs. Female

  Last day of observation period (average of 14.76 weeks)

• Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)

  Last day of observation period (average of 14.76 weeks)

Study Arms (1)

Amlodipine 10mg Tablet

Subjects taking Amlodipine 10mg Tablet.

Drug: Amlodipine

Interventions

Amlodipine DRUG

Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose. Dosage should be adjusted depending on the patient's symptoms. The dose can be raised up to 10 mg once daily for patients who show inadequate response.

Also known as: Norvasc

Amlodipine 10mg Tablet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects who have been treated with amlodipine 5mg at least 4 weeks and had not achieved target BP.

You may qualify if:

• Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks
• The subjects who had not achieved target BP

You may not qualify if:

• Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet 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

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: December 1, 2010
• First Posted: December 3, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: April 2, 2019

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share