Amlodipine 10mg Drug Use Investigation (ENTER10)
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.
|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)|
- 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 ]
- 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 ]
|Study Start Date:||December 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Amlodipine 10mg Tablet
Subjects taking Amlodipine 10mg Tablet.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252563
|Study Director:||Pfizer CT.gov Call Center||Pfizer|