Amlodipine 10mg Drug Use Investigation (ENTER10)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01252563
First received: December 1, 2010
Last updated: January 9, 2014
Last verified: January 2014

December 1, 2010
January 9, 2014
December 2010
November 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01252563 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Amlodipine 10mg Drug Use Investigation
Enhanced Dose Norvasc Treatment For Essential Hypertension In Realworld (Norvasc®10mg Drug Use Investigation)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Hypertension
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
Amlodipine 10mg Tablet
Subjects taking Amlodipine 10mg Tablet.
Intervention: Drug: Amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14141
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01252563
A0531097
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP