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OpenTrials
Completed

NCT Number: NCT00626743

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

To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

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Key information

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

INJE University Pusan Paik Hospital, Pusan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SK3530 100mg, Placebo, Amlodipine

Drug

Primary outcomes

  1. Maximal Change From Baseline in Standing SBP

    Time frame: within 8 hrs after SK3530 or placebo

Secondary outcomes

  1. Maximal Change From Baseline in Standing DBP

    Time frame: within 8 hrs after SK3530 or placebo

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Feb 29, 2008
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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