Evidence map›Paper›PMID 33408462›Full record

Trial reportDrug design, development and therapy2020

Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study.

Soon Jun Hong, Ki-Chul Sung, Sang-Wook Lim, Seok-Yeon Kim, Weon Kim, Jinho Shin, Sungha Park, Hae-Young Kim, Moo-Yong Rhee, HM_APOLLO Investigators

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03897868 (A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT03897868 phase2completednot on this map

A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

TypeinterventionalSponsorHanmi Pharmaceutical Company LimitedRan2019 to 2020Enrolled248ConditionsHypertensionArmsHCP1803, Amlodipine, Losartan, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  5. Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial.Journal of clinical hypertension (Greenwich, Conn.) · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Soon Jun Hong *Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-4832-6678
Ki-Chul Sung *Department of Cardiology, Gangbuk Samsung Hospital, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea.
Sang-Wook LimCardiology Division, Cardiac Center, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
Seok-Yeon KimDepartment of Cardiology, Seoul Medical Center, Seoul, Republic of Korea.
Weon KimDepartment of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea.
Jinho ShinDivision of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-6706-6504
Sungha ParkDepartment of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Hae-Young KimDepartment of Health Policy and Management, College of Health Science & Department of Health Care Science, Graduate School, Korea University, Seoul, Republic of Korea.ORCID 0000-0003-2043-2575
Moo-Yong RheeCardiovascular Center, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi, Republic of Korea.ORCID 0000-0002-1595-3627
HM_APOLLO Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluated the dose-responsiveness, efficacy, and safety of low-dose triple antihypertensive combination therapies in patients with mild-to-moderate hypertension. PATIENTS AND

methodsAfter a 1 to 2-week placebo run-in period, 248 patients were randomized to the half-dose triple combination (amlodipine 2.5 mg + losartan 25 mg + chlorthalidone 6.25 mg), third-dose triple combination (amlodipine 1.67 mg + losartan 16.67 mg + chlorthalidone 4.17 mg), quarter-dose triple combination (amlodipine 1.25 mg + losartan 12.5 mg + chlorthalidone 3.13mg), amlodipine 10mg, amlodipine 5mg, losartan 100mg, and placebo groups for 8 weeks. The primary outcome was the mean change in systolic blood pressure (SBP) from baseline to week 8.

resultsThe placebo-corrected SBP reductions of the half-dose, third-dose, quarter-dose combination, amlodipine 10 mg, amlodipine 5 mg and losartan 100 mg treatments were -17.2, -19.5, -14.9, -18.5, -11.3 and -9.9 mmHg, respectively. The BP control and response rates were significantly higher in the half-dose, third-dose, and quarter-dose combination groups than in the placebo group (all p < 0.01). Despite no intergroup differences in study drug-related adverse events, ankle circumference increased significantly in the amlodipine group compared to those in the combination treatment groups. The quarter-dose combination, amlodipine 5 mg, and losartan 100 mg groups showed similar SBP reduction and BP response rates. The SBP reduction and BP response rate in the third-dose and half-dose combination groups were not significantly different from those in the amlodipine 10 mg group but superior to those in the losartan 100 mg group.

conclusionLow-dose triple combination therapies could be effective as antihypertensive therapies.

trial registrationClinicalTrials.gov identifier NCT03897868.

Indexed as

AgedAmlodipineAntihypertensive AgentsChlorthalidoneDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypertensionLosartanMaleMiddle AgedAmlodipineAntihypertensive AgentsChlorthalidoneLosartanamlodipineblood pressurechlorthalidonecombination therapyhypertensionlosartanlow-dose

Identifiers

PMID33408462
PMCPMC7781016

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Registered trials

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.