Open-label, uncontrolled, clinical trial of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension

Hyeong Cheon Park, Kun Ho Kwon, Hyun Jin Noh, In Hee Lee, Shin-Wook Kang, Kyu Hun Choi, Sung Kyu Ha, Ho Yung Lee, Dae Suk Han, Minoru Yamamoto

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Abstract

Background: Barnidipine hydrochloride is a calcium channel blocker that is administered in a single daily dose. It has been shown to be effective in lowering blood pressure in Japanese patients with essential hypertension, renal parenchymal hypertension, and renovascular hypertension. Objective: The purpose of this study was to assess the antihypertensive efficacy and tolerability of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. Methods: This open-label, uncontrolled study used a doseescalation design, with 5 to 15 mg barnidipine administered once daily for 4 to 8 weeks. Korean patients with renal parenchymal hypertension were enrolled. Results: Of the 31 patients enrolled, 30 (15 men and 25 women; mean age, 45.1 ± 10.4 years; mean body weight, 62.5 ± 10.4 kg; mean sitting systolic blood pressure [SBP], 158.0 ± 13.2 mm Hg; mean diastolic blood pressure [DBP], 101.8 ± 7.1 mm Hg) completed the entire schedule of drug administration. One patient discontinued hospital visits at 2 weeks. In 3 patients treated with barnidipine 5 mg/d for 4 weeks, mean SBP and DBP were 131.7 ± 16.1 mm Hg and 85.0 ± 5.0 mm Hg, respectively, after 4 weeks of treatment compared with 160.0 ± 34.6 mm Hg and 105.0 ± 13.2 mm Hg at baseline. In 15 patients treated with barnidipine 5 mg/d for 2 weeks and 10 mg/d for 4 weeks, mean SBP and DBP were 138.3 ± 7.9 mm Hg and 84.3 ± 8.0 mm Hg, respectively, 6 weeks after treatment compared with 160.7 ± 13.7 mm Hg and 102.7 ± 9.0 mm Hg at baseline (P < 0.05). In 12 patients treated with barnidipine 5 mg/d for 2 weeks, 10 mg/d for 2 weeks, and 15 mg/d for 4 weeks, mean SBP and DBP were 139.6 ± 8.7 nun Hg and 85.8 ± 8.7 mm Hg, respectively, g weeks after treatment compared with 158.3 ± 13.7 nun Hg and 100.8 ± 6.0 mm Hg at baseline (P <0.05). Mean sitting SBP after 4 to 8 weeks of treatment with barnidipine was 139.9 ± 8.5 nun Hg (mean reduction, 18.1 mm Hg [11.4%]) and mean sitting DBP was 85.5 ± 7.5 mm Hg (mean reduction, 16.3 mm Hg [16%]). Sitting heart rate did not change after treatment with barnidipine. Barnidipine was well tolerated; mild adverse events occurred in 5 of 30 patients (17%) and included facial flushing (13%), tachycardia (13%), and headache (7%). Conclusions: The results suggest that barnidipine is effective in reducing systemic hypertension and is well tolerated in this sample of Korean patients with renal parenchymal hypertension. Barnidipine hydrochloride, calcium channel blocker, renal parenchymal hypertension, blood pressure.

Original languageEnglish
Pages (from-to)927-937
Number of pages11
JournalCurrent Therapeutic Research - Clinical and Experimental
Volume61
Issue number12
DOIs
Publication statusPublished - 2000 Jan 1

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Renal Hypertension
Clinical Trials
Blood Pressure
mepirodipine
Calcium Channel Blockers
Drug Administration Schedule

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Park, Hyeong Cheon ; Kwon, Kun Ho ; Noh, Hyun Jin ; Lee, In Hee ; Kang, Shin-Wook ; Choi, Kyu Hun ; Ha, Sung Kyu ; Lee, Ho Yung ; Han, Dae Suk ; Yamamoto, Minoru. / Open-label, uncontrolled, clinical trial of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. In: Current Therapeutic Research - Clinical and Experimental. 2000 ; Vol. 61, No. 12. pp. 927-937.
@article{1984b7ac6f644996b20c2e0603efa547,
title = "Open-label, uncontrolled, clinical trial of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension",
abstract = "Background: Barnidipine hydrochloride is a calcium channel blocker that is administered in a single daily dose. It has been shown to be effective in lowering blood pressure in Japanese patients with essential hypertension, renal parenchymal hypertension, and renovascular hypertension. Objective: The purpose of this study was to assess the antihypertensive efficacy and tolerability of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. Methods: This open-label, uncontrolled study used a doseescalation design, with 5 to 15 mg barnidipine administered once daily for 4 to 8 weeks. Korean patients with renal parenchymal hypertension were enrolled. Results: Of the 31 patients enrolled, 30 (15 men and 25 women; mean age, 45.1 ± 10.4 years; mean body weight, 62.5 ± 10.4 kg; mean sitting systolic blood pressure [SBP], 158.0 ± 13.2 mm Hg; mean diastolic blood pressure [DBP], 101.8 ± 7.1 mm Hg) completed the entire schedule of drug administration. One patient discontinued hospital visits at 2 weeks. In 3 patients treated with barnidipine 5 mg/d for 4 weeks, mean SBP and DBP were 131.7 ± 16.1 mm Hg and 85.0 ± 5.0 mm Hg, respectively, after 4 weeks of treatment compared with 160.0 ± 34.6 mm Hg and 105.0 ± 13.2 mm Hg at baseline. In 15 patients treated with barnidipine 5 mg/d for 2 weeks and 10 mg/d for 4 weeks, mean SBP and DBP were 138.3 ± 7.9 mm Hg and 84.3 ± 8.0 mm Hg, respectively, 6 weeks after treatment compared with 160.7 ± 13.7 mm Hg and 102.7 ± 9.0 mm Hg at baseline (P < 0.05). In 12 patients treated with barnidipine 5 mg/d for 2 weeks, 10 mg/d for 2 weeks, and 15 mg/d for 4 weeks, mean SBP and DBP were 139.6 ± 8.7 nun Hg and 85.8 ± 8.7 mm Hg, respectively, g weeks after treatment compared with 158.3 ± 13.7 nun Hg and 100.8 ± 6.0 mm Hg at baseline (P <0.05). Mean sitting SBP after 4 to 8 weeks of treatment with barnidipine was 139.9 ± 8.5 nun Hg (mean reduction, 18.1 mm Hg [11.4{\%}]) and mean sitting DBP was 85.5 ± 7.5 mm Hg (mean reduction, 16.3 mm Hg [16{\%}]). Sitting heart rate did not change after treatment with barnidipine. Barnidipine was well tolerated; mild adverse events occurred in 5 of 30 patients (17{\%}) and included facial flushing (13{\%}), tachycardia (13{\%}), and headache (7{\%}). Conclusions: The results suggest that barnidipine is effective in reducing systemic hypertension and is well tolerated in this sample of Korean patients with renal parenchymal hypertension. Barnidipine hydrochloride, calcium channel blocker, renal parenchymal hypertension, blood pressure.",
author = "Park, {Hyeong Cheon} and Kwon, {Kun Ho} and Noh, {Hyun Jin} and Lee, {In Hee} and Shin-Wook Kang and Choi, {Kyu Hun} and Ha, {Sung Kyu} and Lee, {Ho Yung} and Han, {Dae Suk} and Minoru Yamamoto",
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doi = "10.1016/S0011-393X(00)90020-1",
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Open-label, uncontrolled, clinical trial of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. / Park, Hyeong Cheon; Kwon, Kun Ho; Noh, Hyun Jin; Lee, In Hee; Kang, Shin-Wook; Choi, Kyu Hun; Ha, Sung Kyu; Lee, Ho Yung; Han, Dae Suk; Yamamoto, Minoru.

In: Current Therapeutic Research - Clinical and Experimental, Vol. 61, No. 12, 01.01.2000, p. 927-937.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Open-label, uncontrolled, clinical trial of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension

AU - Park, Hyeong Cheon

AU - Kwon, Kun Ho

AU - Noh, Hyun Jin

AU - Lee, In Hee

AU - Kang, Shin-Wook

AU - Choi, Kyu Hun

AU - Ha, Sung Kyu

AU - Lee, Ho Yung

AU - Han, Dae Suk

AU - Yamamoto, Minoru

PY - 2000/1/1

Y1 - 2000/1/1

N2 - Background: Barnidipine hydrochloride is a calcium channel blocker that is administered in a single daily dose. It has been shown to be effective in lowering blood pressure in Japanese patients with essential hypertension, renal parenchymal hypertension, and renovascular hypertension. Objective: The purpose of this study was to assess the antihypertensive efficacy and tolerability of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. Methods: This open-label, uncontrolled study used a doseescalation design, with 5 to 15 mg barnidipine administered once daily for 4 to 8 weeks. Korean patients with renal parenchymal hypertension were enrolled. Results: Of the 31 patients enrolled, 30 (15 men and 25 women; mean age, 45.1 ± 10.4 years; mean body weight, 62.5 ± 10.4 kg; mean sitting systolic blood pressure [SBP], 158.0 ± 13.2 mm Hg; mean diastolic blood pressure [DBP], 101.8 ± 7.1 mm Hg) completed the entire schedule of drug administration. One patient discontinued hospital visits at 2 weeks. In 3 patients treated with barnidipine 5 mg/d for 4 weeks, mean SBP and DBP were 131.7 ± 16.1 mm Hg and 85.0 ± 5.0 mm Hg, respectively, after 4 weeks of treatment compared with 160.0 ± 34.6 mm Hg and 105.0 ± 13.2 mm Hg at baseline. In 15 patients treated with barnidipine 5 mg/d for 2 weeks and 10 mg/d for 4 weeks, mean SBP and DBP were 138.3 ± 7.9 mm Hg and 84.3 ± 8.0 mm Hg, respectively, 6 weeks after treatment compared with 160.7 ± 13.7 mm Hg and 102.7 ± 9.0 mm Hg at baseline (P < 0.05). In 12 patients treated with barnidipine 5 mg/d for 2 weeks, 10 mg/d for 2 weeks, and 15 mg/d for 4 weeks, mean SBP and DBP were 139.6 ± 8.7 nun Hg and 85.8 ± 8.7 mm Hg, respectively, g weeks after treatment compared with 158.3 ± 13.7 nun Hg and 100.8 ± 6.0 mm Hg at baseline (P <0.05). Mean sitting SBP after 4 to 8 weeks of treatment with barnidipine was 139.9 ± 8.5 nun Hg (mean reduction, 18.1 mm Hg [11.4%]) and mean sitting DBP was 85.5 ± 7.5 mm Hg (mean reduction, 16.3 mm Hg [16%]). Sitting heart rate did not change after treatment with barnidipine. Barnidipine was well tolerated; mild adverse events occurred in 5 of 30 patients (17%) and included facial flushing (13%), tachycardia (13%), and headache (7%). Conclusions: The results suggest that barnidipine is effective in reducing systemic hypertension and is well tolerated in this sample of Korean patients with renal parenchymal hypertension. Barnidipine hydrochloride, calcium channel blocker, renal parenchymal hypertension, blood pressure.

AB - Background: Barnidipine hydrochloride is a calcium channel blocker that is administered in a single daily dose. It has been shown to be effective in lowering blood pressure in Japanese patients with essential hypertension, renal parenchymal hypertension, and renovascular hypertension. Objective: The purpose of this study was to assess the antihypertensive efficacy and tolerability of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. Methods: This open-label, uncontrolled study used a doseescalation design, with 5 to 15 mg barnidipine administered once daily for 4 to 8 weeks. Korean patients with renal parenchymal hypertension were enrolled. Results: Of the 31 patients enrolled, 30 (15 men and 25 women; mean age, 45.1 ± 10.4 years; mean body weight, 62.5 ± 10.4 kg; mean sitting systolic blood pressure [SBP], 158.0 ± 13.2 mm Hg; mean diastolic blood pressure [DBP], 101.8 ± 7.1 mm Hg) completed the entire schedule of drug administration. One patient discontinued hospital visits at 2 weeks. In 3 patients treated with barnidipine 5 mg/d for 4 weeks, mean SBP and DBP were 131.7 ± 16.1 mm Hg and 85.0 ± 5.0 mm Hg, respectively, after 4 weeks of treatment compared with 160.0 ± 34.6 mm Hg and 105.0 ± 13.2 mm Hg at baseline. In 15 patients treated with barnidipine 5 mg/d for 2 weeks and 10 mg/d for 4 weeks, mean SBP and DBP were 138.3 ± 7.9 mm Hg and 84.3 ± 8.0 mm Hg, respectively, 6 weeks after treatment compared with 160.7 ± 13.7 mm Hg and 102.7 ± 9.0 mm Hg at baseline (P < 0.05). In 12 patients treated with barnidipine 5 mg/d for 2 weeks, 10 mg/d for 2 weeks, and 15 mg/d for 4 weeks, mean SBP and DBP were 139.6 ± 8.7 nun Hg and 85.8 ± 8.7 mm Hg, respectively, g weeks after treatment compared with 158.3 ± 13.7 nun Hg and 100.8 ± 6.0 mm Hg at baseline (P <0.05). Mean sitting SBP after 4 to 8 weeks of treatment with barnidipine was 139.9 ± 8.5 nun Hg (mean reduction, 18.1 mm Hg [11.4%]) and mean sitting DBP was 85.5 ± 7.5 mm Hg (mean reduction, 16.3 mm Hg [16%]). Sitting heart rate did not change after treatment with barnidipine. Barnidipine was well tolerated; mild adverse events occurred in 5 of 30 patients (17%) and included facial flushing (13%), tachycardia (13%), and headache (7%). Conclusions: The results suggest that barnidipine is effective in reducing systemic hypertension and is well tolerated in this sample of Korean patients with renal parenchymal hypertension. Barnidipine hydrochloride, calcium channel blocker, renal parenchymal hypertension, blood pressure.

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