Evidence map›Paper›PMID 25693004›Full record

Trial reportPloS one2015

A randomized, double blind, placebo-controlled, multicenter phase II trial of Allisartan Isoproxil in essential hypertensive population at low-medium risk.

Ying Li, Xiao-hui Li, Zhi-jun Huang, Guo-ping Yang, Guo-gang Zhang, Shui-ping Zhao, Ying Guo, Shi-juan Lu, Jian-lin Ma, Fan-bo Meng and 2 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  5. Efficacy and safety of sacubitril/allisartan for the treatment of primary hypertension: a phase 2 randomized, double-blind study.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Ying LiCenter of Clinical Pharmacology, the Third Xiangya hospital, Central South University, Changsha, China.
Xiao-hui LiDepartment of Pharmacology, School of Pharmaceutical Sciences, Central South University, Changsha, China.
Zhi-jun HuangCenter of Clinical Pharmacology, the Third Xiangya hospital, Central South University, Changsha, China.
Guo-ping YangCenter of Clinical Pharmacology, the Third Xiangya hospital, Central South University, Changsha, China.
Guo-gang ZhangDepartment of Cardiovascular Medicine, Xiangya Hospital, Central South University, Changsha, China.
Shui-ping ZhaoDepartment of Cardiology, the Second Xiangya Hospital, Central South University, Changsha, China.
Ying GuoDepartment of Cardiology, Hunan Provincial People's Hospital, Changsha, China.
Shi-juan LuDepartment of Cardiology, Haikou City People's Hospital, Haikou, China.
Jian-lin MaDepartment of Cardiology, Hainan Provincial People's Hospital, Haikou, China.
Fan-bo MengDepartment of Cardiology, China Japan Union Hospital of Jilin University, Changchun, China.
Ping ChenDepartment of Cardiology, Shantou Central Hospital, Shantou, China.
Hong YuanCenter of Clinical Pharmacology, the Third Xiangya hospital, Central South University, Changsha, China.
Central South University · CNHunan Provincial People's Hospital · CNJilin University · CNSecond Xiangya Hospital of Central South University · CNShantou Central Hospital · CNXiangya Hospital Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAngiotensin II receptor blockers (ARBs) is a well-tolerated class of antihypertensive agents, exhibiting effective antihypertensive and cardiovascular protective function. The objective of the study was to examine the efficacy and safety of Allisartan Isoproxil, a newly developed, selective, nonpeptide blocker of the angiotensin II type 1 receptor (AT1R), in essential hypertensive patients at low-medium risk. METHODS AND

findingsA Phase II prospective, randomized, double-blind, placebo-controlled, multicenter trial comparing Allisartan Isoproxil 240mg versus placebo was conducted in essential hypertensive patients at low-medium risk at 8 sites in China. After a 2-week placebo baseline period, 275 patients received once-daily treatment with Allisartan Isoproxil 240mg or placebo randomly for 8 weeks. Systolic/diastolic blood pressure (SBP/DBP) was measured at week 2, 4 and 8. By the end of treatment, mean reductions from baseline of SBP and DBP in Allisartan Isoproxil and placebo groups were 14.5/10.4 and 8.3/7.7 mmHg, respectively (P<0.01). The rate of effective blood pressure control in Allisartan Isoproxil group was significantly higher than in placebo group at week 4 (61.3% vs 50.0%, P<0.05) and week 8 (67.2% vs 48.6%, P<0.01). In terms of safety and tolerability, there were no report of death and serious adverse event (SAE) in all subjects. There was no difference of frequency between two groups in adverse event (AE) and adverse drug reaction (ADR) (P>0.05). No one withdraw because of an ADR in two groups. 124 patients received additional 56 weeks treatment with Allisartan Isoproxil and 84 of them completed the study. The rate of effective BP control kept up to 80% since week 24. No significant clinical change was observed and ADRs were generally mild or moderate during the long-term study. CONCLUSIONS/SIGNIFICANCE: Allisartan Isoproxil 240mg was effective and safe for essential hypertension patients at low-medium risk.

trial registrationhttp://www.chictr.org/cn/ ChiCTR-TRC-10000886.

Indexed as

Angiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBiphenyl CompoundsDouble-Blind MethodEndpoint DeterminationEssential HypertensionFemaleHumansHypertensionImidazolesMaleMiddle AgedPlacebosRiskSafetyallisartan isoproxilAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBiphenyl CompoundsImidazolesPlacebos

Identifiers

PMID25693004
PMCPMC4333341
OpenAlexW2077168804

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.