Unique ID issued by UMIN | UMIN000013460 |
---|---|
Receipt number | R000015717 |
Scientific Title | Efficacy and safety of Exforge and Aimix in hypertensives |
Date of disclosure of the study information | 2014/03/18 |
Last modified on | 2015/03/18 09:19:50 |
Efficacy and safety of Exforge and Aimix in hypertensives
Examiner study
Efficacy and safety of Exforge and Aimix in hypertensives
Examiner study
Japan |
Hypertension
Cardiology |
Others
NO
Combinations of angiotensin II type 1 receptor blockers (ARBs) and calcium channel blockers (CCBs) are recommended by various guidelines for the treatment of high blood pressure. Many kinds of single-pill fixed-dose combinations of ARBs and CCBs are available for clinical use in Japan. It is still controversial what types of single-pill fixed-dose combinations of ARBs and CCBs are useful. Therefore, we compared the efficacies and safety of two kinds of a single-pill fixed-dose combination of ARBs and CCBs (valsartan and amlodipine vs. irbesartan and amlodipine).
Safety,Efficacy
Exploratory
Explanatory
Not applicable
1.Depressor effects at office blood pressure and the percentage of patients who reach the target office blood pressure.
2.Depressor effects at home blood pressure and the percentage of patients who reach the target home blood pressure.
1.Percentage of adverse effects.
2.Changes in biochemical parameters in blood and urine.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
The patients with hypertension under treatment with valsartan 80 mg/day or amlodipine 5 mg/day (a single-pill fixed-dose combination) are enrolled. The patients receive a single-pill fixed-dose combination of irbesartan 100 mg/day and amlodipine 5 mg/day instead of valsartan 80 mg/day or amlodipine 5 mg/day and treated for 16 weeks. If the patient did not reach the target office BP at 8 weeks according to Japanese Society of Hypertension Guideline 2009, they received double doses of amlodipine.
The patients with hypertension under treatment with valsartan 80 mg/day or amlodipine 5 mg/day (a single-pill fixed-dose combination) are enrolled. The patients receive same single-pill fixed-dose combination and treated for 16 weeks. If the patient did not reach the target office BP at 8 weeks according to Japanese Society of Hypertension Guideline 2009, they received double doses of amlodipine.
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients with essential hypertension who received a single-pill fixed dose combination of valsartan and amlodipine at least for 8 weeks.
2.Age is 20 years old or more.
3.Patients who gave their informed consent to participate for the present study.
1.Severe liver dysfunction.
2.Severe renal dysfunction.
3.Pregnancy or lactation in women.
4.Patients with a history of allergy to any component of the study medications.
5.Patients corresponding to the contraindication of study medications.
6.Ineligible patients according to the judgment by physician.
60
1st name | |
Middle name | |
Last name | Keijiro Saku |
Fukuoka University School of Medicine
Department of Cardiology
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
81-92-801-1011
saku-k@fukuoka-u.ac.jp
1st name | |
Middle name | |
Last name | Shin-ichiro Miura |
Fukuoka University School of Medicine
Department of Cardiology
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
81-92-801-1011
miuras@cis.fukuoka-u.ac.jp
Department of Cardiology,Fukuoka University School of Medicine.
Department of Cardiology,Fukuoka University School of Medicine.
Self funding
Japan
NO
福岡大学病院(福岡県)、出水総合医療センター(鹿児島県)、井上病院(福岡県)、藤沢内科(福岡県)、松永病院(福岡県)
2014 | Year | 03 | Month | 18 | Day |
Unpublished
Completed
2013 | Year | 02 | Month | 08 | Day |
2013 | Year | 05 | Month | 30 | Day |
2014 | Year | 10 | Month | 30 | Day |
2014 | Year | 11 | Month | 30 | Day |
2014 | Year | 11 | Month | 30 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 03 | Month | 18 | Day |
2015 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015717
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |