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A 8week, Multi-center, Randomized, Double blinded, Double dummy, Parallel-group Comparative Phase 3 Clinical trial to Assess the Efficacy and Safety of Amlodipine maleate Compared to Amlodipine besylate in Patients with Mild-to-moderate Hypertension
ÀÓ»ó¾à¸®ÇÐȸÁö 2005³â 13±Ç 1È£ p.64 ~ p.83
ÀÌÇüµ·(Lee Hyoung-Don) - ¼¿ïÀÇ·á¿ø ¼øȯ±â³»°ú
±è¼®¿¬(Kim Seok-Yeon) - ¼¿ïÀÇ·á¿ø ¼øȯ±â³»°ú
ÇѺÀÁØ(Han Bong-Jun) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
°Çü¹Î(Kang Hyun-Min) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
¹ÚÀçÀº(Park Jae-Eun) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
°ÁøÈ£(Kang Jin-Ho) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
±è¹ü¼ö(Kim Bum-Soo) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
¼º±âö(Sung Ki-Chul) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
±èº´Áø(Kim Byung-Jin) - ¼º±Õ°ü´ëÇб³ ÀÇ°ú´ëÇÐ ¼øȯ±â³»°úÇб³½Ç
±èÁø¿ì(Kim Jin-Woo) - ¿ï»ê´ëÇб³ ÀÇ°ú´ëÇÐ °¸ª¾Æ»êº´¿ø ¼øȯ±â ³»°ú
Çã½ÂÈ£(Hur Seung-Ho) - °è¸í´ëÇб³ ÀÇ°ú´ëÇÐ µ¿»êÀÇ·á¿ø ³»°ú
±è±â½Ä(Kim Ki-Sik) - °è¸í´ëÇб³ µ¿»êÀÇ·á¿ø ¼øȯ±â³»°ú
ÀÌÀαÔ(Lee In-Kyu) - °è¸í´ëÇб³ µ¿»êÀÇ·á¿ø ¼øȯ±â³»°ú
±èÇý¼ø(Kim Hey-Soon) - °è¸í´ëÇб³ µ¿»êÀÇ·á¿ø ¼øȯ±â³»°ú
±è¹ÌÁ¤(Kim Mi-Jung) - °è¸í´ëÇб³ µ¿»êÀÇ·á¿ø ¼øȯ±â³»°ú
±èö¹Î(Kim Chul-Min) - °¡Å縯´ëÇб³ ÀÇ°ú´ëÇÐ ¼ººó¼¾Æ®º´¿ø ¼øȯ±â³»°úÇб³½Ç
Abstract
Background & Objectives : Calcium channel blockers(CCB) have been used primary antihyperetensives. among them, second generation CCB, amlodipine besylate(Norvasc), has been used worldwide recent 10years because of it¡¯¡¯s high bioavailibility and long half life. but, non-besylate amlodipine such as amlodipine maleate has not been used even though it¡¯¡¯s many biochemical, pharmacological and toxicological information. so, we compared amlodipine besylate with amlodipne maleate in anti-hyperetensive activity and safety.
Methods :We used 8weeks, multi-center, randomized, double blinded, double dummy, parallel-group comparative phase 3 clinical trial to assess the efficacy and safety of amlodipine maleate compared to amlodipine besylate in patients with mild-to-moderate hypertension.
Results :In anti-hyperertensive efficacy, the mean declines in sDBP was 12.8{\pm}6.5mmHg vs 1l.5{pm}7.3mmHg in each cases. difference is 1.2mmHg, and this is meaningless statistically. In safety, there were several side effects such as rash, urticaria, headache, insomnia and so on. But, no severe side effects and statistically meaningful differences were noted in each cases. According to our study, there are little differences between amlodipine besylate and amlodipine maleate in efficacy and safety.
Conclusions :Besylate and maleate, are just carriers of amlodipine in the body. amlodipine itself acts on the net anti-hypertensive effect. so, we found that amlodipine besylate and amlodipine maleate show nearly same anti-hypertensive effect and safety regardless of their salt compounds.
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KMID :
0391020050130010064
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À¯È¿¼º°á°ú(Recomendation)
There are little differences between amlodipine besylate and amlodipine maleate in efficacy and safety.