PMID- 29235365
OWN - NLM
STAT- MEDLINE
DCOM- 20181119
LR  - 20181119
IS  - 1651-1999 (Electronic)
IS  - 0803-7051 (Linking)
VI  - 27
IP  - 3
DP  - 2018 Jun
TI  - A phase III, open-label, multicenter study to evaluate the safety and efficacy of 
      long-term triple combination therapy with azilsartan, amlodipine, and 
      hydrochlorothiazide in patients with essential hypertension.
PG  - 125-133
LID - 10.1080/08037051.2017.1412797 [doi]
AB  - PURPOSE: Patients with essential hypertension who are receiving treatment with an 
      angiotensin II receptor blocker and a calcium channel blocker often develop 
      inadequate blood pressure (BP) control and require the addition of a diuretic. 
      This study aimed to evaluate the long-term safety and efficacy of a triple 
      combination therapy with 20 mg azilsartan (AZL), 5 mg amlodipine (AML) and 
      12.5 mg hydrochlorothiazide (HCTZ). MATERIALS AND METHODS: The phase III, 
      open-label, multicenter study (NCT02277691) comprised a 4-week run-in period and 
      52-week treatment period. Patients with inadequate BP control despite AZL/AML 
      therapy (n = 341) received 4 weeks' treatment with AZL/AML (combination 
      tablet) + HCTZ (tablet) and 4 weeks' treatment with AZL/AML/HCTZ (combination 
      tablet) in a crossover manner, followed by AZL/AML/HCTZ (combination tablet) from 
      Week 8 of the treatment period up to Week 52. The primary and secondary endpoints 
      were long-term safety and BP (office and home), respectively. RESULTS: Most 
      adverse events (AEs) were mild or moderate in intensity, and no deaths or 
      treatment-related serious AEs were reported. The triple therapy provided 
      consistent BP-lowering effects in both office and home measurements. CONCLUSIONS: 
      The triple combination therapy with AZL/AML/HCTZ was well tolerated and effective 
      for 52 weeks in Japanese patients with essential hypertension.
FAU - Rakugi, Hiromi
AU  - Rakugi H
AD  - a Department of Geriatric and General Medicine , Osaka University Graduate School 
      of Medicine , Osaka , Japan.
FAU - Shimizu, Kohei
AU  - Shimizu K
AD  - b Takeda Development Center Japan , Takeda Pharmaceutical Company Limited , Osaka 
      , Japan.
FAU - Nishiyama, Yuya
AU  - Nishiyama Y
AD  - b Takeda Development Center Japan , Takeda Pharmaceutical Company Limited , Osaka 
      , Japan.
FAU - Sano, Yuhei
AU  - Sano Y
AD  - b Takeda Development Center Japan , Takeda Pharmaceutical Company Limited , Osaka 
      , Japan.
FAU - Umeda, Yuusuke
AU  - Umeda Y
AD  - b Takeda Development Center Japan , Takeda Pharmaceutical Company Limited , Osaka 
      , Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02277691
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20171213
PL  - England
TA  - Blood Press
JT  - Blood pressure
JID - 9301454
RN  - 0 (Benzimidazoles)
RN  - 0 (Oxadiazoles)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - 1J444QC288 (Amlodipine)
RN  - F9NUX55P23 (azilsartan)
SB  - IM
EIN - Blood Press. 2018 Jun;27(3):184. PMID: 29357704
MH  - Adult
MH  - Aged
MH  - Amlodipine/therapeutic use
MH  - Benzimidazoles/therapeutic use
MH  - Blood Pressure/drug effects
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination/adverse effects/*methods
MH  - Essential Hypertension/*drug therapy
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Oxadiazoles/therapeutic use
OTO - NOTNLM
OT  - Azilsartan
OT  - Hypertension
OT  - amlodipine
OT  - angiotensin II receptor blocker (ARB)
OT  - calcium channel blocker (CCB)
OT  - diuretic
OT  - hydrochlorothiazide
OT  - triple combination therapy
EDAT- 2017/12/14 06:00
MHDA- 2018/11/20 06:00
CRDT- 2017/12/14 06:00
PHST- 2017/12/14 06:00 [pubmed]
PHST- 2018/11/20 06:00 [medline]
PHST- 2017/12/14 06:00 [entrez]
AID - 10.1080/08037051.2017.1412797 [doi]
PST - ppublish
SO  - Blood Press. 2018 Jun;27(3):125-133. doi: 10.1080/08037051.2017.1412797. Epub 
      2017 Dec 13.