HypertensionPhase 1NCT00626743
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
A Phase 1 study of Hypertension, run by SK Chemicals Co., Ltd. at 2 sites in South Korea.
Trial summary
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men only
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2008to Jul 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects 19-65 years of age inclusive
- Subjects with hypertension as defined 100 mmHg ≤ SBP<140 mmHg and 65 mmHg ≤ DBP < 90 mmHg after more than 5 minutes in the supine position
- Written informed consent
- Willing and able to comply with the requirements of the protocol
Who cannot join
- Subjects with acute or chronic disease within 4 weeks of study initiation.
- Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
- Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
- Subjects with clinically significant abnormalities on laboratory tests
- Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
- Subjects with abnormal QTc interval(≥440ms)
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- Subjects with color-blindness or weakness
- Subejcts with alcohol, drug or caffeine abuse
- Diet known to alter drug absorption, distribution, metabolism or elimination processes
- Subjects who participated in other clinical studies within 2 months before an administration
- Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
INJE University Pusan Paik Hospital
Pusan
Asan Medical Center
Seoul
About this study
Official title: Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
- Conditions
- Hypertension
- Being tested
- SK3530 100mg, Placebo, Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK3530 100mg, Placebo, AmlodipineDrug
| Study group | Role | What they receive |
|---|---|---|
| SK3530 | Experimental | Active Drug Receives: Drug: SK3530 100mg, Placebo, Amlodipine |
| Placebo | Placebo comparator | Tablet which has the same appearance and taste but doesn't contain active ingredient Receives: Drug: SK3530 100mg, Placebo, Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Change From Baseline in Standing SBP
Measured: within 8 hrs after SK3530 or placebo
Secondary outcomes (1)
Maximal Change From Baseline in Standing DBP
Measured: within 8 hrs after SK3530 or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Gook Shin, MD,PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626743
- Sponsor's protocol ID
- SK3530_AMD_I_2007
- Status last verified
- Mar 2014
- First submitted
- 21 Feb 2008
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine
- ClinicalTrials.gov ID
- NCT00626743
- Acronym / sponsor ID
- SK3530_AMD_I_2007
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SK3530 | Experimental | Drug: SK3530 100mg, Placebo, AmlodipineActive Drug |
| Placebo | Placebo comparator | Drug: SK3530 100mg, Placebo, AmlodipineTablet which has the same appearance and taste but doesn't contain active ingredient |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects 19-65 years of age inclusive
- Subjects with hypertension as defined 100 mmHg ≤ SBP<140 mmHg and 65 mmHg ≤ DBP < 90 mmHg after more than 5 minutes in the supine position
- Written informed consent
- Willing and able to comply with the requirements of the protocol
Key exclusion criteria (11 listed)
- Subjects with acute or chronic disease within 4 weeks of study initiation.
- Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
- Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
- Subjects with clinically significant abnormalities on laboratory tests
- Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
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 |
|---|---|---|
| SK3530 100mg, Placebo, Amlodipine | Drug | Placebo, SK3530 |
Primary outcome
Maximal Change From Baseline in Standing SBP
Time frame: within 8 hrs after SK3530 or placebo
1 secondary outcome
Maximal Change From Baseline in Standing DBP
Time frame: within 8 hrs after SK3530 or placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jae Gook Shin, MD,PhD principal investigator
Inje University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Hypertension, run by SK Chemicals Co., Ltd. at 2 sites 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 11 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximal Change From Baseline in Standing SBP (time frame: within 8 hrs after SK3530 or placebo). 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 21 Apr 2014.