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

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

      • Pusan, Korea, Republic of
        • Inje University Pusan Paik Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center

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.

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

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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