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COMPLETED Phase 1

Drug Interaction Study of Avanafil and Enalapril or Amlodipine

NCT01117038 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG avanafil and enalapril
  • DRUG avanafil and amlodipine

Study Locations (1)

Arizona

  • Celerion — Tempe

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2010-04
Est. Completion 2010-05
Phase Phase 1

Sponsor

VIVUS

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01117038

The ClinicalTrials.gov registry entry for NCT01117038 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 2 interventions — of which avanafil and enalapril is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01117038 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01117038 about?

NCT01117038 is a clinical study titled "Drug Interaction Study of Avanafil and Enalapril or Amlodipine". 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.

What is the current status of trial NCT01117038?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2010-04. Estimated completion is 2010-05.

What conditions does trial NCT01117038 study?

This clinical trial studies the following conditions: Erectile Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01117038?

The interventions under investigation include: avanafil and enalapril (DRUG), avanafil and amlodipine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01117038?

This trial is sponsored by VIVUS, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01117038 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial