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Essential HypertensionPhase 2NCT01878201

A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension

A Phase 2 study testing Fimasartan and Valsartan in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd 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 Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Essential Hypertension
What is being tested?
Fimasartan and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSouth Korea
Study dates
May 2013to Feb 2014
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects aged 20 to 70 years
  • Essential hypertension subjects who are measured more 135/85 mmHg of average Diastolic Blood pressure (DBP) and Systolic Blood pressure (SBP) measured by ABP monitor at baseline visit(day 0)
  • Subjects who agreed to participate in this study and submitted the written informed consent
  • Subjects who considered to understand this study, be cooperative, and able to be followed-up whole of the study period

Who cannot join

  • Severe hypertension patients; more 180 mmHg of mean sitting SBP and/or more 110 mmHg of mean sitting DBP measured as an office Blood pressure (BP), before Randomization (Screening visit, Placebo run-in visit, Pre-Baseline visit, Baseline visit)
  • Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
  • Patients with secondary hypertension
  • Patients with symptomatic orthostatic hypotension
  • Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
  • Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
Show all 26Show fewer
  • Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
  • Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
  • Patients with severe cerebrovascular disease within 6 months
  • Patients with known severe or malignancy retinopathy within 6 months
  • Patients with wasting disease, autoimmune disease, connective tissue disease
  • Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (Aspartate Transaminase(AST), Alanine Transaminase(ALT) more 2 times than upper normal)
  • Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
  • Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
  • Patients with depletion of body fluid or sodium ion not able to correct
  • Patients with suspected or history of drug or alcohol abuse within the past two years
  • Childbearing, breast-feeding women and female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
  • Patients with any chronic inflammation disease needed to chronic inflammation therapy
  • Patients with hepatitis type B or type C and carriers
  • Patients with laboratory test results indicating clinically significant abnormal results
  • Patients receiving medication that can affect blood pressure
  • Patients with history of allergic reaction to any angiotensin II antagonist
  • Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
  • Patients who took investigational drug within 12 weeks from screening visit or is going on the progress of other clinical trial
  • Subject who are judged unsuitable to participate in this study by investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, Seoul, 110-744

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension

The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension

Being tested
Fimasartan, Valsartan
Keywords
Fimasartan, 24 hours ABP monitoring(ABPM), antihypertension
Medical subject headings
Essential Hypertension

What participants receive

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

  • FimasartanDrug

    Also called Kanarb

    Fimasartan 30 mg

  • ValsartanDrug

    Also called Diovan

    Valsartan 80 mg

Study groups in NCT01878201
Study groupRoleWhat they receive
Fimasartan 30 mgExperimentalTake one capsule filled with a Fimasartan 30 mg in the every morning
Receives: Drug: Fimasartan
Valsartan 80 mgActive comparatorTake one capsule filled with a Valsartan 80 mg in the every morning
Receives: Drug: Valsartan

What is being measured

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

  1. Mean Systolic Blood Pressure during 24 hours

    To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit

    Measured: 8 weeks from baseline visit

Secondary outcomes (5)

  1. Mean Diastolic Blood Pressure during 24 hours

    To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit

    Measured: 8 weeks from baseline visit

  2. Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime

    To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit

    Measured: 8 weeks from baseline visit

  3. Sitting Diastolic Blood pressure and Systolic Blood pressure

    To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit

    Measured: 8 weeks from baseline visit

  4. Trough-to-peak ratio

    Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor

    Measured: 8 weeks from baseline visit

  5. Smoothness index

    Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor

    Measured: 8 weeks from baseline visit

Timeline

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

  1. First posted14 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878201
Sponsor's protocol ID
A657-BR-CT-L201
Status last verified
Sep 2014
First submitted
31 May 2013
Last updated
8 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fimasartan and Valsartan in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd 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 4 inclusion and 26 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 8 Sep 2014. 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?

Mean Systolic Blood Pressure during 24 hours (time frame: 8 weeks from baseline visit). 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 NCT01878201.

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 8 Sep 2014.

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