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HypertensionPhase 2NCT00942344

Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

A Phase 2 study testing Amlodipine plus Losartan, Amlodipine and Losartan in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Amlodipine plus Losartan, Amlodipine and Losartan
How many people
320 participants
Where
1 siteSouth Korea
Study dates
May 2007to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged between 18 and 75
  • Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period}

Who cannot join

  • Patients with mean sitSBP ≥ 200 mmHg
  • Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
  • Patients with secondary hypertension or suspected secondary hypertension
  • Patients with malignant hypertension
  • Patients who have received any medications with possible interactions with study drugs
  • Patients with uncontrolled diabetes
Show all 12Show fewer
  • Patients with severe heart disease or severe cerebrovascular disease
  • Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
  • Patients with a history of malignant disease
  • Patients with a history of autoimmune disease
  • Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
  • Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • 14 sites in Korea

    Seoul, Busan, Etc.

Other trials in South Korea

About this study

Official title: An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Conditions
Hypertension
Being tested
Amlodipine plus Losartan, Amlodipine, Losartan
Keywords
Amlodipine, Losartan, Hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amlodipine plus LosartanDrug

    Also called Amosartan

    amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg

  • AmlodipineDrug

    amlodipine 5mg, 10mg

  • LosartanDrug

    Losartan 50mg, 100mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average changes from baseline in sitDBP

    Measured: Week 8

Secondary outcomes (3)

  1. Average changes from baseline in sitDBP

    Measured: Week 4

  2. Average changes from baseline in sitSBP

    Measured: Week 4, 8

  3. Blood pressure responder rate

    Measured: Week 4, 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2009 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00942344
Sponsor's protocol ID
HM-ALOS-201
Status last verified
Jul 2009
First submitted
17 Jul 2009
Last updated
20 Jul 2009
Results posted
No
Data monitoring committee
No

Publications

  • Park CG, Youn HJ, Chae SC, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Hong BK, Jeong JW, Park SH, Kwan J, Choi YJ, Cho SY. Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter study. Am J Cardiovasc Drugs. 2012 Feb 1;12(1):35-47. doi: 10.2165/11597170-000000000-00000.

    PubMed 22217192

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlodipine plus Losartan, Amlodipine and Losartan in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average changes from baseline in sitDBP (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00942344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2009.

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