- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626743
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
March 13, 2014 updated by: SK Chemicals Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Pusan, Korea, Republic of
- Inje University Pusan Paik Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SK3530
Active Drug
|
|
Placebo Comparator: Placebo
Tablet which has the same appearance and taste but doesn't contain active ingredient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal Change From Baseline in Standing SBP
Time Frame: within 8 hrs after SK3530 or placebo
|
within 8 hrs after SK3530 or placebo
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal Change From Baseline in Standing DBP
Time Frame: within 8 hrs after SK3530 or placebo
|
within 8 hrs after SK3530 or placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 21, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (Estimate)
February 29, 2008
Study Record Updates
Last Update Posted (Estimate)
April 21, 2014
Last Update Submitted That Met QC Criteria
March 13, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SK3530_AMD_I_2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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