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CompletedNCT00940680Updated Jul 16, 2009

Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension

A Phase 3 interventional study of Amlodipine plus Losartan and Losartan in Hypertension, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-16.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension

Keywords

  • Amlodipine
  • Losartan
  • hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 142 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients over 18 years of age
  • Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)
  • Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)

Exclusion criteria

Exclusion Criteria:

  • mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
  • mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment
  • has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
  • Secondary hypertensive patient or suspected to be
  • Uncontrolled diabetes mellitus patients
  • Severe heart disease or severe neurovascular disease
  • Known as severe or malignant retinopathy
  • Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
  • History of malignancy tumor
  • History of autoimmune disease
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, has an intention on pregnancy
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    amlodipine/losartan 5/100mg

    Drug: Amlodipine plus Losartan

  • Active comparator
    losartan 100mg

    Drug: Losartan

Interventions

  • DrugAmlodipine plus Losartan

    amlodipine/losartan 5/100mg q.d.

    Also known as: Amosartan

  • DrugLosartan

    losartan 100mg q.d.

06

What researchers measure

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure

    Time frame: Week 4

  2. Change from baseline in mean sitting systolic blood pressure

    Time frame: Week 4, 8

  3. Responder rate

    Time frame: Week 4, 8

07

Study locations

1 site
  • 9 sites in Korea
    Seoul, Daegu, etc., Korea, Republic of
08

References and documents

Publications

  • Hong BK, Park CG, Kim KS, Yoon MH, Yoon HJ, Yoon JH, Yang JY, Choi YJ, Cho SY. Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):189-95. doi: 10.2165/11597410-000000000-00000. PubMed 22462558 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00940680
Lead sponsor
Hanmi Pharmaceutical Company Limited
First posted
Jul 16, 2009
Start date
Apr 2008
Primary completion
Nov 2008
Completion
Nov 2008
Last update
Jul 16, 2009

Study contacts

Seung-Yun Cho, M.D., Ph.D.
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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