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NCT00940667

A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy

Completed Phase 3 Last updated 10 October 2016
What this trial tests

Phase 3 trial testing Amlodipine plus Losartan in Hypertension in 185 participants. Completed in 1 December 2008.

Timeline
1 May 2008
Primary endpoint
1 December 2008
1 December 2008

Quick facts

Lead sponsorHanmi Pharmaceutical Company Limited
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment185
Start date1 May 2008
Primary completion1 December 2008
Estimated completion1 December 2008
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Hanmi Pharmaceutical Company Limited — full company profile →

Who can join

18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority
    Kang SM, Youn JC, Chae SC, Park CG, et al · · 2011 · cited 14× · PMID 22136978 · DOI 10.1016/j.clinthera.2011.11.007
  2. Evaluation of blood pressure reduction response and responder characteristics to fixed-dose combination treatment of amlodipine and losartan: a post hoc analysis of pooled clinical trials.
    Unniachan S, Wu D, Rajagopalan S, Hanson ME, et al · · 2014 · cited 5× · PMID 25098858 · DOI 10.1111/jch.12390

Verify or expand the search:

Other trials of Amlodipine plus Losartan

Trials testing the same drug.

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other Hanmi Pharmaceutical Company Limited trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00940667.

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