NCT00940667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

July 14, 2009

Last Update Submit

October 10, 2016

Conditions

Hypertension

Keywords

AmlodipineLosartanhypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean sitting diastolic blood pressure

    Week 8

Secondary Outcomes (3)

  • Change from baseline in mean sitting diastolic blood pressure

    Week 4

  • Change from baseline in mean sitting systolic blood pressure

    Week 4, 8

  • Responder rate

    Week 4, 8

Study Arms (2)

amlodipine/losartan 5/50mg

EXPERIMENTAL
Drug: Amlodipine plus Losartan

amlodipine 5mg

ACTIVE COMPARATOR
Drug: Amlodipine

Interventions

Amlodipine plus LosartanDRUG

amlodipine/losartan 5/50mg q.d.

Also known as: Amosartan
amlodipine/losartan 5/50mg
AmlodipineDRUG

amlodipine 5mg q.d.

Also known as: Amodpine
amlodipine 5mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ≥ 95 mmHg for drug-naïve patient)
  • Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)

You may not qualify if:

  • mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
  • mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

13 sites in Korea

Seoul, Busan, Etc., South Korea

Location

Related Publications (1)

  • Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jeong JW, Yoon JH, Park SH, Kwon J, Cho SY. 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 study. Clin Ther. 2011 Dec;33(12):1953-63. doi: 10.1016/j.clinthera.2011.11.007. Epub 2011 Dec 2.

    PMID: 22136978DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

AmlodipineLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesTetrazoles

Study Officials

  • Seung-Yun Cho, M.D., Ph.D.

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 16, 2009

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

KR(1)