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Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil (ALERT)

This study has been completed.
Sponsor:
Information provided by:
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00903981
First received: May 18, 2009
Last updated: April 22, 2010
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.


Condition Intervention Phase
Erectile Dysfunction
 Drug: Avanafil
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Confirmatory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

Resource links provided by NLM:

Drug Information available for: Avanafil
U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Change of EF domain score in the IIEF(The International Index of Erectile Function) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of successful rate in SEPQ2,Q3,Q4,Q5 Change of score in other domains of IIEF Change of IIEF Q3 and Q4 score GEAQ The rate of normal erectile function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avanafil 100mg Drug: Avanafil
2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse
Experimental: Avanafil 200mg Drug: Avanafil
2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse
Placebo Comparator: Placebo Drug: Placebo
2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months
  • subjects have stable monogamous relationships
  • their partners are free from pregnancy and lactation and well prevent conception
  • subjects consented to participate in the clinical study in writing
  • subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50%

Exclusion Criteria:

  • history of spinal cord injury or radical prostatectomy
  • subjects whose penises are anatomically deformed
  • erectile dysfunction due to neurogenic or endocrine cause
  • subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities
  • history of cancer chemotherapy within 1 year
  • subjects who are addicted to alcohol or have continuously misused dependent drugs
  • subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serum creatinine > 2.0)
  • subjects who have uncontrollable diabetes(FPG>180)
  • subjects sho have proliferative diabetic retinopathy
  • history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months
  • serious hypotension or uncontrollable severe hypertension
  • hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
  • subjects who have retinitis pigmentosa
  • subjects who suffered from serious GI bleeding disorder within 1 year
  • subjects who took other PDE5 inhibitors or ED therapies within 2 weeks
  • subjects who use non-concomitant medications(Nitrate/NO donors, Androgens, anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit the activity of CYP3A4)
  • history of hypersensitivity to the PDE5 inhibitors or not responded to them
  • subjects who have hypoactive sexual desire
  • subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
  • subjects who took other investigational products within 30 days before this clinical study
  • subjects who are judged to be unsuitable to the clinical study by other reasons
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903981

Locations
Korea, Republic of
Chonbuk national university hospital
Chonju, Cholabukdo, Korea, Republic of, 561-712
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Jong Kwan Park, PhD Chonbuk National University Hospital
Principal Investigator: Se Woong Kim, PhD Catholic Seoul medical center
Principal Investigator: Jae Suk Hyun, PhD Gyeongsang National University Hospital
Principal Investigator: Je Jong Kim, PhD Korea University
Principal Investigator: Nam Cheol Park, PhD Pusan National University Hospital
Principal Investigator: Sung Won Lee, PhD Samsung Medical Center
Principal Investigator: Jae Seung Paick, PhD Seoul National University Hospital
Principal Investigator: Tae young Ahn, PhD Asan Medical Center
Principal Investigator: Ki Hak Moon, PhD Yeungnam University
Principal Investigator: Woo Sik Chung, PhD Ewha womans university hospital
Principal Investigator: Kweon Sik Min, PhD Inje university Pusan paick hospital
Principal Investigator: Jun Kyu Suh, PhD Inha University Hospital
Principal Investigator: Kwang Sung Park, PhD Chonnam National University Hospital
Principal Investigator: Dae Yul Yang, PhD Kangdong Sacred Heart Hospital
  More Information

No publications provided

Responsible Party: ChoongWae Pharma Corporation(Hyun Yoon Jeong), ChoongWae Pharma Corporation
ClinicalTrials.gov Identifier: NCT00903981     History of Changes
Other Study ID Numbers: CWP-AVA-301
Study First Received: May 18, 2009
Last Updated: April 22, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
 Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013