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Amlodipine 10mg Drug Use Investigation (ENTER10)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01252563
First received: December 1, 2010
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Amlodipine
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enhanced Dose Norvasc Treatment For Essential Hypertension In Realworld (Norvasc®10mg Drug Use Investigation)

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: 12 weeks ] [ Designated as safety issue: No ]
  • The achievement rate to Blood Pressure Goal. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Risk factors likely to affect the efficacy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15000
Study Start Date: December 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Amlodipine 10mg Tablet
Subjects taking Amlodipine 10mg Tablet.
 Drug: Amlodipine
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.
Other Name: Norvasc

Detailed Description:

All the subjects whom an investigator prescribes Amlodipine (Norvasc®) 10mg Tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252563

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: NCT01252563     History of Changes
Other Study ID Numbers: A0531097
Study First Received: December 1, 2010
Last Updated: May 13, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
ENTER10
Hypertension
Japanese
Norvasc 10mg
Post Marketing surveillance

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
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 16, 2013