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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00626743
First received: February 21, 2008
Last updated: March 13, 2014
Last verified: March 2014
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal Change From Baseline in Standing DBP [ Time Frame: within 8 hrs after SK3530 or placebo ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00626743     History of Changes
Other Study ID Numbers: SK3530_AMD_I_2007
Study First Received: February 21, 2008
Results First Received: March 13, 2014
Last Updated: March 13, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014