HypertensionPhase 4NCT01828359
The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
A Phase 4 study testing Amosartan® tab and Cozaar® plus pro tab in people with Hypertension, run by Hanmi Pharmaceutical Company Limited.
Trial summary
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Amosartan® tab and Cozaar® plus pro tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 aged or over
- Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)
Who cannot join
- Patients with too high Blood pressure
- •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
- Secondary hypertension or suspected to be
About this study
Official title: An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.
Read the detailed description
- Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
- Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
- Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA
- Conditions
- Hypertension
- Being tested
- Amosartan® tab, Cozaar® plus pro tab
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amosartan® tabDrug
Also called Amlodipine 5mg /Losartan 100mg
comparison of different combination of anti-hypertension drug
Cozaar® plus pro tabDrug
Also called Losartan 100mg/ HCTZ 12.5mg
comparison of different combination of anti-hypertension drug
| Study group | Role | What they receive |
|---|---|---|
| Amosartan® tab | Experimental | Amlodipine 5mg /Losartan 100mg Receives: Drug: Amosartan® tab |
| Cozaar® plus pro tab | Active comparator | Losartan 100mg/ HCTZ 12.5mg Receives: Drug: Cozaar® plus pro tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: Baseline, Week 8
Secondary outcomes (3)
Change from baseline in MSDBP
Measured: Baseline, week 4
Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)
Measured: Baseline, Week 4 and 8
Blood pressure responder rate
Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg and MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.
Measured: Baseline, Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taehoon Ahn, Ph.D., Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828359
- Sponsor's protocol ID
- HM-ALOS-401
- Status last verified
- Apr 2013
- First submitted
- 7 Apr 2013
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy
- ClinicalTrials.gov ID
- NCT01828359
- Acronym / sponsor ID
- HM-ALOS-401
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Apr 2013 (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 blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.
Detailed description
- Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
- Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
- Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amosartan® tab | Experimental | Drug: Amosartan® tabAmlodipine 5mg /Losartan 100mg |
| Cozaar® plus pro tab | Active comparator | Drug: Cozaar® plus pro tabLosartan 100mg/ HCTZ 12.5mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 aged or over
- Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)
Key exclusion criteria (4 listed)
- Patients with too high Blood pressure
- •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
- Secondary hypertension or suspected to be
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 |
|---|---|---|
| Amosartan® tabAlso: Amlodipine 5mg /Losartan 100mgcomparison of different combination of anti-hypertension drug | Drug | Amosartan® tab |
| Cozaar® plus pro tabAlso: Losartan 100mg/ HCTZ 12.5mgcomparison of different combination of anti-hypertension drug | Drug | Cozaar® plus pro tab |
Primary outcome
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: Baseline, Week 8
3 secondary outcomes
Change from baseline in MSDBP
Time frame: Baseline, week 4
Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)
Time frame: Baseline, Week 4 and 8
Blood pressure responder rate
Time frame: Baseline, Week 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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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.
Taehoon Ahn, Ph.D. principal investigator
Gachon University Gil Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amosartan® tab and Cozaar® plus pro tab in people with Hypertension, run by Hanmi Pharmaceutical Company Limited.
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 3 inclusion and 4 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 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) (time frame: Baseline, Week 8). 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 Apr 2013.