2007Chinese Journal of New Drugs and Clinical RemediesRequires access

Cilnidipine capsule in treatment of essential hypertension:a double-blind,double-dummy,multicenter,randomized,controlled trial

Chen Huan-qin, Sha N

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Abstract

AIM:To assess the clinical efficacy and safety of domestic cilnidipine capsule in treatment of mild and moderate essential hypertension.METHODS:In a double-blind,double-dummy,muhicenter, randomized,controlled trial,the antihypertensive effects and safety of cilnidipine capsule were compared with cilnidipine tablet in 252 patients with mild to moderate essential hypertension.RESULTS:After 8 wk treatment, mean sitting systolic blood pressure and diastolic blood pressure decreased(18±s 11)mmHg(11.9 %)and (12±8)mmHg(12.6 %)in cilnidipine capsule group while(19±13)mmHg(12.5%)and(12±8)mmHg (12.9 %)in cilnidipine tablet group,respectively.The total effective rate of cilnidipine capsule was 80.3 % and that of cilnidipine tablet was 82.9 %.The change of heart rates was not significant in both groups.There were 6 drug relatively adverse reactions in cilnidipine capsule group and 4 in cilnidipine tablet group.The adverse drug reactions were mild and moderate dizziness,headache,palpitation,and face flushing.There was no significant difference of clinical efficacy and safety between the two groups(P>0.05).CONCLUSION: Similar with domestic cilnidipine tablet,domestic cilnidipine capsule is effective and safe in treatment of mild to moderate essential hypertension.

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AIM:To assess the clinical efficacy and safety of domestic cilnidipine capsule in treatment of mild and moderate essential hypertension.METHODS:In a double-blind,double-dummy,muhicenter, randomized,controlled trial,the antihypertensive effects and safety of cilnidipine capsule were compared with cilnidipine tablet in 252 patients with mild to moderate essential hypertension.RESULTS:After 8 wk treatment, mean sitting systolic blood pressure and diastolic blood pressure decreased(18±s 11)mmHg(11.9 %)and (12±8)mmHg(12.6 %)in cilnidipine capsule group while(19±13)mmHg(12.5%)and(12±8)mmHg (12.9 %)in cilnidipine tablet group,respectively.The total effective rate of cilnidipine capsule was 80.3 % and that of cilnidipine tablet was 82.9 %.The change of heart rates was not significant in both groups.There were 6 drug relatively adverse reactions in cilnidipine capsule group and 4 in cilnidipine tablet group.The adverse drug reactions were mild and moderate dizziness,headache,palpitation,and face flushing.There was no significant difference of clinical efficacy and safety between the two groups(P>0.05).CONCLUSION: Similar with domestic cilnidipine tablet,domestic cilnidipine capsule is effective and safe in treatment of mild to moderate essential hypertension.

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Available abstract

AIM:To assess the clinical efficacy and safety of domestic cilnidipine capsule in treatment of mild and moderate essential hypertension.METHODS:In a double-blind,double-dummy,muhicenter, randomized,controlled trial,the antihypertensive effects and safety of cilnidipine capsule were compared with cilnidipine tablet in 252 patients with mild to moderate essential hypertension.RESULTS:After 8 wk treatment, mean sitting systolic blood pressure and diastolic blood pressure decreased(18±s 11)mmHg(11.9 %)and (12±8)mmHg(12.6 %)in cilnidipine capsule group while(19±13)mmHg(12.5%)and(12±8)mmHg (12.9 %)in cilnidipine tablet group,respectively.The total effective rate of cilnidipine capsule was 80.3 % and that of cilnidipine tablet was 82.9 %.The change of heart rates was not significant in both groups.There were 6 drug relatively adverse reactions in cilnidipine capsule group and 4 in cilnidipine tablet group.The adverse drug reactions were mild and moderate dizziness,headache,palpitation,and face flushing.There was no significant difference of clinical efficacy and safety between the two groups(P>0.05).CONCLUSION: Similar with domestic cilnidipine tablet,domestic cilnidipine capsule is effective and safe in treatment of mild to moderate essential hypertension.

Key concepts: Medicine, Capsule, Essential hypertension, Blood pressure, Randomized controlled trial, Adverse effect, Anesthesia, Double blind

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