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Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626743
First Posted: February 29, 2008
Last Update Posted: April 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
  Purpose
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

Condition Intervention Phase
Hypertension Drug: SK3530 100mg, Placebo, Amlodipine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • Maximal Change From Baseline in Standing SBP [ Time Frame: within 8 hrs after SK3530 or placebo ]

Secondary Outcome Measures:
  • Maximal Change From Baseline in Standing DBP [ Time Frame: within 8 hrs after SK3530 or placebo ]

Enrollment: 13
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SK3530
Active Drug
Drug: SK3530 100mg, Placebo, Amlodipine
Placebo Comparator: Placebo
Tablet which has the same appearance and taste but doesn't contain active ingredient
Drug: SK3530 100mg, Placebo, Amlodipine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626743


Locations
Korea, Republic of
INJE University Pusan Paik Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Jae Gook Shin, MD,PhD Inje University
  More Information

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00626743     History of Changes
Other Study ID Numbers: SK3530_AMD_I_2007
First Submitted: February 21, 2008
First Posted: February 29, 2008
Results First Submitted: March 13, 2014
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents