Essential HypertensionPhase 4NCT00366119
Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension
A Phase 4 study testing Ramipril in people with Essential Hypertension, run by Pacific Pharmaceuticals at 1 site in South Korea.
Trial summary
The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Ramipril
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Jun 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)
Who cannot join
- 180mmHg≤SBP
- If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings
- If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings
- impaired hepatic function
- imapaired renal function
- angioedema
Show all 13Show fewer
- aortic valvular stenosis or obstrcutive ejection disorder
- primary hyperaldosteronism
- renal transplantation, bilateral renal artery stenosis or unilateral stenosis in a single kidney, hemodialysis
- severe respiratory disease
- congestive heart failure( New York Association functional class Ⅲ or Ⅳ)
- malignant hypertension
- labile angina pectoris or myocardial infarction in the last 3 months before study entry
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, 28 Yeongeon-dong, Jongno-gu, 110-744
About this study
Official title: Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension
The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension
- Conditions
- Essential Hypertension
- Being tested
- Ramipril
- Keywords
- hypertension, ramipril, blood pressure, artery stiffness, BNP, CRP
- 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.
RamiprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of DBP(diastolic blood pressure)
Secondary outcomes (7)
Reduction of SBP(systolic blood pressure)
Percentage of patients with Dcrease of BP(blood pressure)
Percentage of patients with a Normalization of BP(blood pressure)
Artery stiffness(chang of pulse wave velocity)
Left ventricular diastolic function
Change of BNP
Change of CRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startJun 2006
- Study completionJun 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- Pacific Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- HyoSoo Kim, Ph.D in MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366119
- Sponsor's protocol ID
- RMN-P01
- Status last verified
- Mar 2007
- First submitted
- 17 Aug 2006
- Last updated
- 9 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension
- ClinicalTrials.gov ID
- NCT00366119
- Acronym / sponsor ID
- RMN-P01
- Conditions
- Essential Hypertension
- Keywords
- hypertension, ramipril, blood pressure, artery stiffness, BNP, CRP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants
- Lead sponsor
- Pacific PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jun 2007
- First posted
- 18 Aug 2006 (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 assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)
Key exclusion criteria (13 listed)
- 180mmHg≤SBP
- If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings
- If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings
- impaired hepatic function
- imapaired renal function
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 |
|---|---|---|
| Ramipril | Drug | – |
Primary outcome
Reduction of DBP(diastolic blood pressure)
7 secondary outcomes
Reduction of SBP(systolic blood pressure)
Percentage of patients with Dcrease of BP(blood pressure)
Percentage of patients with a Normalization of BP(blood pressure)
Artery stiffness(chang of pulse wave velocity)
Left ventricular diastolic function
Change of BNP
Change of CRP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2007.
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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.
HyoSoo Kim, Ph.D in MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramipril in people with Essential Hypertension, run by Pacific Pharmaceuticals 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 1 inclusion and 13 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 9 Mar 2007. 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 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?
Results are not available in the source record.
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?
Reduction of DBP(diastolic blood pressure). 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 9 Mar 2007.