NCT01616485

Brief Summary

The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

June 7, 2012

Last Update Submit

June 12, 2012

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in hemodynamic measurements

    Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.

    Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.

Study Arms (3)

Treatment A

EXPERIMENTAL

TA-1790 + glyceryl trinitrate

Drug: TA-1790Drug: Nitrostat

Treatment B

ACTIVE COMPARATOR

sildenafil citrate + glyceryl trinitrate

Drug: Sildenafil citrateDrug: Nitrostat

Treatment C

PLACEBO COMPARATOR

placebo + glyceryl trinitrate

Drug: PlaceboDrug: Nitrostat

Interventions

TA-1790DRUG

2 TA-1790 100 mg capsules

Treatment A
Sildenafil citrateDRUG

2 sildenafil citrate 50 mg capsules

Treatment B
PlaceboDRUG

2 placebo capsules for TA-1790 100 mg capsules

Treatment C
NitrostatDRUG

glyceryl trinitrate tablet, USP 0.4 mg

Treatment ATreatment BTreatment C

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provide written informed consent
  • Willing to comply with all study requirements and clinic schedules
  • Male between 30 to 60 years of age
  • Non-smoker
  • No history of alcohol abuse
  • Normal screening laboratory values

You may not qualify if:

  • Allergy or hypersensitive to PDE5 inhibitors
  • Evidence of clinically significant disease
  • Supine systolic/diastolic blood pressure level
  • History of cardiovascular disease
  • Previously participated in TA-1790 within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Phoenix, Arizona, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil CitrateNitroglycerin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitro Compounds

Study Officials

  • Craig Peterson, MS

    VIVUS LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

March 1, 2004

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)