Essential HypertensionPhase 3NCT01413048
Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension
A Phase 3 study testing Carvedilol 25mg and AGSCT101 12.5mg in people with Essential Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Carvedilol 25mg and AGSCT101 12.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Sep 2012
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients ≥ 19 years of age
- Mild to moderate essential hypertension: sDBP 90 ~ 109, sSBP 140 ~ 179
- Subjects who agree to participate in this sudy and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Who cannot join
- The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg
- Patients with postural hypotension
- Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease
- Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
- Patients judged to have a history of alcohol or drug abuse by the investigator
- Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
- Patients with uncontrolled diabetes mellitus
- Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea-St. Mary's Hospital
Seoul
Ki-bae Seung, Professor, +82-2-2258-1148
About this study
Official title: Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.
Read the detailed description
This study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of AGSCT101 versus Carvedilol in patient with stage 1 to 2 essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- Carvedilol 25mg, AGSCT101 12.5mg
- Keywords
- Essential Hypertension, Hypertension
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol 25mgDrug
Tablet, q.d.
AGSCT101 12.5mgDrug
Tablet, q.d.
| Study group | Role | What they receive |
|---|---|---|
| AGSCT101 | Experimental | Not described Receives: Drug: AGSCT101 12.5mg |
| Carvedilol | Active comparator | Not described Receives: Drug: Carvedilol 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in diastolic blood pressure (DBP)
Measured: 8 weeks
Secondary outcomes (4)
Change from baseline in diastolic blood pressure (DBP)
Measured: 2 weeks
Change from baseline in systolic blood pressure (SBP)
Measured: 2, 8 weeks
Proportion of patients who reach overall blood pressure control (defined as BP <140/90)
Measured: 8 weeks
Incidence of adverse effects
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ki-Bae Seung, Professor, Principal investigator, The Catholic University of Korea-St. Mary's HospitalHun-Sik Park, Professor, Principal investigator, Kyungpook National University HospitalChang-Gyu Park, Professor, Principal investigator, Korea University Guro HospitalMoo-Yong Rhee, Professor, Principal investigator, Dongguk University Medical CenterDong-Ju Choi, Professor, Principal investigator, Seoul National University Bundang HospitalSeung-Jea Tahk, Professor, Principal investigator, Ajou University School of MedicineJung-Han Yoon, Professor, Principal investigator, Wonju Christian HospitalSung-Ha Park, Professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413048
- Sponsor's protocol ID
- 1001AGCVSP3
- Status last verified
- Aug 2011
- First submitted
- 7 Aug 2011
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension
- ClinicalTrials.gov ID
- NCT01413048
- Acronym / sponsor ID
- 1001AGCVSP3
- Conditions
- Essential Hypertension
- Keywords
- Essential Hypertension, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.
Detailed description
This study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of AGSCT101 versus Carvedilol in patient with stage 1 to 2 essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGSCT101 | Experimental | Drug: AGSCT101 12.5mg |
| Carvedilol | Active comparator | Drug: Carvedilol 25mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients ≥ 19 years of age
- Mild to moderate essential hypertension: sDBP 90 ~ 109, sSBP 140 ~ 179
- Subjects who agree to participate in this sudy and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Key exclusion criteria (8 listed)
- The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg
- Patients with postural hypotension
- Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease
- Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
- Patients judged to have a history of alcohol or drug abuse by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol 25mgTablet, q.d. | Drug | Carvedilol |
| AGSCT101 12.5mgTablet, q.d. | Drug | AGSCT101 |
Primary outcome
Change from baseline in diastolic blood pressure (DBP)
Time frame: 8 weeks
4 secondary outcomes
Change from baseline in diastolic blood pressure (DBP)
Time frame: 2 weeks
Change from baseline in systolic blood pressure (SBP)
Time frame: 2, 8 weeks
Proportion of patients who reach overall blood pressure control (defined as BP <140/90)
Time frame: 8 weeks
Incidence of adverse effects
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-Bae Seung, Professor principal investigator
The Catholic University of Korea-St. Mary's Hospital
Hun-Sik Park, Professor principal investigator
Kyungpook National University Hospital
Chang-Gyu Park, Professor principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carvedilol 25mg and AGSCT101 12.5mg in people with Essential Hypertension, run by Ahn-Gook Pharmaceuticals 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 8 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: status not confirmed, as of the sponsor's last update on 10 Aug 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Young Yoon, Manager (+82-2-3289-4257, syyoon@ahn-gook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in diastolic blood pressure (DBP) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2011.