check_circleStudy Completed
Hypertension
Bayer Identifier:
15190
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Post-marketing Surveillance for hypertensive patients with diabetes and/or chronic kidney disease
Trial purpose
This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
1882Trial Dates
November 2009 - July 2013Phase
N/ACould I Receive a placebo
NoProducts
Adalat CC (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Evaluation of participants with Adverse Events for Safety purpose in real practicedate_rangeTime Frame:After 6 monthsenhanced_encryptionYesSafety Issue:
- General evaluation of patient concerning efficacy of AdalatCR treatment in real practicedate_rangeTime Frame:After 6 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Blood pressure, Pulse ratedate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
- Clinical test values, in specially, microalbumin urea and serum creatininedate_rangeTime Frame:After 6 monthsenhanced_encryptionYesSafety Issue:
- Overall evaluationdate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A