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Drug Interaction Study of Avanafil and Enalapril or Amlodipine

NCT01117038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-08-10

No results posted yet for this study

Summary

The purpose of this study is to determine the change in the blood pressure and pulse rate, pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.

Conditions

Interventions

DRUG

avanafil and enalapril

enalapril twice a day for 11 days avanafil/placebo once a day for 2 days

DRUG

avanafil and amlodipine

amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Shiyin Yee, PhD · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01117038 on ClinicalTrials.gov