テルミサルタン/ヒドロクロロチアジド単剤とテルミサルタン/ヒドロクロロチアジド＋アムロジピンの有効性および安全性の比較
基本情報
- NCT ID
- NCT01911780
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 132
- 治験依頼者名
- Boehringer Ingelheim
概要
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg. In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period. In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.
対象疾患
介入
依頼者（Sponsor）
実施施設 (34)
1348.2.005 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, Japan
1348.2.009 Boehringer Ingelheim Investigational Site
Nishi-ku, Fukuoka, Fukuoka, Japan
1348.2.016 Boehringer Ingelheim Investigational Site
Uji, Kyoto, Japan
1348.2.021 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.001 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan
1348.2.014 Boehringer Ingelheim Investigational Site
Kiyota-ku, Sapporo-shi, Hokkaido, Japan
1348.2.012 Boehringer Ingelheim Investigational Site
Hirakata, Osaka, Japan
1348.2.001 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan
1348.2.002 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto, Japan
1348.2.011 Boehringer Ingelheim Investigational Site
Kasaoka, Okayama, Japan
1348.2.008 Boehringer Ingelheim Investigational Site
Chuo-ku, Fukuoka, Fukuoka, Japan
1348.2.020 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1348.2.013 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.019 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka-shi, Osaka, Japan
1348.2.002 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto, Japan
1348.2.009 Boehringer Ingelheim Investigational Site
Nishi-ku, Fukuoka, Fukuoka, Japan
1348.2.010 Boehringer Ingelheim Investigational Site
Yoshikawa, Saitama, Japan
1348.2.011 Boehringer Ingelheim Investigational Site
Kasaoka, Okayama, Japan
1348.2.010 Boehringer Ingelheim Investigational Site
Yoshikawa, Saitama, Japan
1348.2.005 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, Japan
1348.2.007 Boehringer Ingelheim Investigational Site
Nakano-ku,Tokyo, Japan
1348.2.021 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.018 Boehringer Ingelheim Investigational Site
Chuo-ku,Kobe, Hyogo, Japan
1348.2.008 Boehringer Ingelheim Investigational Site
Chuo-ku, Fukuoka, Fukuoka, Japan
1348.2.006 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.007 Boehringer Ingelheim Investigational Site
Nakano-ku,Tokyo, Japan
1348.2.012 Boehringer Ingelheim Investigational Site
Hirakata, Osaka, Japan
1348.2.006 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.013 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1348.2.016 Boehringer Ingelheim Investigational Site
Uji, Kyoto, Japan
1348.2.014 Boehringer Ingelheim Investigational Site
Kiyota-ku, Sapporo-shi, Hokkaido, Japan
1348.2.019 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka-shi, Osaka, Japan
1348.2.020 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1348.2.018 Boehringer Ingelheim Investigational Site
Chuo-ku,Kobe, Hyogo, Japan