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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by SK Chemicals Co.,Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00626743
First received: February 21, 2008
Last updated: February 16, 2009
Last verified: March 2008
History of Changes
  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, 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:

U.S. FDA Resources

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, supine DBP/SBP & HR [ Time Frame: within 8 hrs after SK3530 or placebo ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Period 1 : Amlodipine, SK3530 Period 2 : Amlodipine, Placebo
 Drug: SK3530, Amlodipine
dosing time
Active Comparator: 2
Period 1 : Amlodipine, Placebo Period 2 : Amlodipine, SK3530
 Drug: SK3530, Amlodipine
dosing time

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 19 to 65
  • Hypertensive patient

Exclusion Criteria:

  • Simple appendectomy,herniotomy,gastrointestinal disease
  • Color-blindness or weakness
  • Abnormal QTc (>440 ms)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626743

Contacts
Contact: SK chemicals +82-2-2008-2008

Locations
Korea, Republic of
INJE University Pusan Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Jae Gook Shin, MD,PhD            
SK chemicals Recruiting
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Jae Gook Shin, MD,PhD Inje University
  More Information

No publications provided

Responsible Party: Clinical research team, 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
Last Updated: February 16, 2009
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013