Post-Marketing Surveillance of MICAMLO Combination Tablets on the Long-term Use
In Japan, post approval conduct of Post Marketing Surveillance (PMS) is requested by Japanese Pharmaceutical Affairs Law (J-PAL) in order to collect safety and efficacy data for re-evaluation of the drugs, which is called re-examination. After 8 years from approval of new substance (4 years from new indication), the results of Post Marketing Surveillance (PMS) need to be submitted to Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
The data used in the New Drug Application (NDA) submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on June 2009 was insufficient to evaluate the safety profile of combination of telmisartan and amlodipine in Japanese population with hypertension. There were only 419 patients in PhIII trials for 8 weeks and only 261 patients in PhIII long-term trials for 56 weeks. Moreover, these safety profiles of Micamlo Combination Tablets AP were investigated in trials which may be quite different from the routine clinical settings in that these trials consisted of frequent visits, strict restriction of concomitant drugs and relatively short observation period.
Since telmisartan is mainly excreted via biliary excretion, clearance of telmisartan may be reduced in patients with hepatic disorder. It has been reported outside of Japan that blood concentration of this product was increased 3-4.5 fold in patients with hepatic disorder. Since amlodipine is mainly metabolized in the liver, the blood half-life may prolong and the area under the blood concentration-time curve (AUC) may increase in patients with serious hepatic dysfunction.
In view of the above, we have decided to newly conduct survey in hypertension patients with or without hepatic dysfunction to collect the safety and efficacy data of Micamlo Combination Tablets AP in the routine clinical settings for application of re-examination.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Post-Marketing Surveillance of MICAMLO Combination Tablets on the Long-term Use|
- Causal relationship of adverse event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The Intensity of adverse event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The changes between baseline and observation period in blood pressure [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Patients with hypertension||
Telmiartan plus Amlodipine T40/A5
Show 254 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim Pharmaceuticals|