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

NCT00626743 | Completed Phase 1 Results

• 1 other identifier: SK3530_AMD_I_2007
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Maximal Change From Baseline in Standing SBP

  within 8 hrs after SK3530 or placebo

Secondary Outcomes (1)

• Maximal Change From Baseline in Standing DBP

  within 8 hrs after SK3530 or placebo

Study Arms (2)

SK3530

EXPERIMENTAL

Active Drug

Drug: SK3530 100mg, Placebo, Amlodipine

Placebo

PLACEBO COMPARATOR

Tablet which has the same appearance and taste but doesn't contain active ingredient

Drug: SK3530 100mg, Placebo, Amlodipine

Interventions

SK3530 100mg, Placebo, Amlodipine DRUG

Placebo; SK3530

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (2)

INJE University Pusan Paik Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jae Gook Shin, MD,PhD
• Organization: INJE University Pusan Paik Hospital

phshinjg@paik.ac.kr

+82-51-890-8954

Study Officials

• Jae Gook Shin, MD,PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2011
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

KR (2)