Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo

A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01616485

Enrollment

106

Registered

2012-06-11

Start date

2004-03-31

Completion date

2004-05-31

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

DRUGTA-1790

2 TA-1790 100 mg capsules

DRUGSildenafil citrate

2 sildenafil citrate 50 mg capsules

DRUGPlacebo

2 placebo capsules for TA-1790 100 mg capsules

DRUGNitrostat

glyceryl trinitrate tablet, USP 0.4 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

30 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in hemodynamic measurements	Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.	Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026