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COMPLETED Phase 4

Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

NCT01415531 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Nebivolol

Study Locations (20)

California

  • Forest Investigative Site 049 — Buena Park
  • Forest Investigative Site 034 — Burbank
  • Forest Investigative Site 039 — Costa Mesa
  • Forest Investigative Site 024 — Fountain Valley
  • Forest Investigative Site 020 — Fresno
  • Forest Investigative Site 021 — Fresno
  • Forest Investigative Site 040 — Greenbrae
  • Forest Investigative Site 047 — La Mesa
  • Forest Investigative Site 073 — Los Angeles
  • Forest Investigative Site 077 — Roseville
  • Forest Investigative Site 060 — San Bernardino
  • Forest Investigative Site 054 — San Francisco
  • Forest Investigative Site 018 — Spring Valley

Arizona

  • Forest Investigative Site 065 — Phoenix
  • Forest Investigative Site 067 — Phoenix
  • Forest Investigative Site 070 — Phoenix

Florida

  • Forest Investigative Site 059 — Brooksville
  • Forest Investigative Site 033 — Fort Lauderdale
  • Forest Investigative Site 006 — Hallandale

Colorado

  • Forest Investigative Site 028 — Denver

Trial Details

FieldValue
Enrollment Target 641 participants
Start Date 2011-08
Est. Completion 2012-04
Phase Phase 4

Sponsor

Forest Laboratories

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01415531

The ClinicalTrials.gov registry entry for NCT01415531 describes a study currently listed as completed. It is categorized as Phase 4, 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 641 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 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 Hypertension appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT01415531 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Florida. 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 NCT01415531 about?

NCT01415531 is a clinical study titled "Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)". The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

What is the current status of trial NCT01415531?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 641 participants. The study started on 2011-08. Estimated completion is 2012-04.

What conditions does trial NCT01415531 study?

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

What interventions are being tested in trial NCT01415531?

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

Who is sponsoring clinical trial NCT01415531?

This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01415531 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida. 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