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NCT01218100 · ClinicalTrials.gov registry record · Phase 4

Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

A Phase 4 study of Stage 2 Diastolic Hypertension, sponsored by Forest Laboratories.

Completed
Registry status
Phase 4
Development phase
664
Enrollment target
20
Study locations

NCT01218100 is a Phase 4 study of Stage 2 Diastolic Hypertension that has completed, run by Forest Laboratories. The registered enrollment target is 664 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT01218100, a Phase 4 study of Stage 2 Diastolic Hypertension, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 4
Development phase
664 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).

Interventions

  • DRUG placebo
  • DRUG nebivolol and lisinopril (free combination)
  • DRUG nebivolol monotherapy
  • DRUG lisinopril monotherapy

Study Locations (20)

California

  • Forest Investigative site 038 - Buena Park
  • Forest Investigative site 075 - Burbank
  • Forest Investigative site 042 - Costa Mesa
  • Forest Investigative site 028 - Fountain Valley
  • Forest Investigative site 064 - Fresno
  • Forest Investigative site 079 - Lancaster
  • Forest Investigative site 097 - Long Beach
  • Forest Investigative site 049 - Los Angeles
  • Forest Investigative site 081 - Riverside
  • Forest Investigative site 040 - San Marino
  • Forest Investigative site 059 - San Ramon
  • Forest Investigative site 074 - Santa Ana
  • Forest Investigative site 072 - Tustin

Arizona

  • Forest Investigative Site #58 - Scottsdale
  • Forest Investigative site 080 - Tempe
  • Forest Investigative site 096 - Tucson

Florida

  • Forest Investigative site 019 - Boca Raton
  • Forest Investigative site 056 - Brandon

Colorado

  • Forest Investigative site 077 - Colorado Springs

Connecticut

  • Forest Investigative site 050 - Waterbury

Trial Details

FieldValue
Enrollment Target 664 participants
Start Date 2010-10
Est. Completion 2011-06
Phase Phase 4

Sponsor

Forest Laboratories

145 total trials

What the Registry Record Tells You About NCT01218100

The ClinicalTrials.gov registry entry for NCT01218100 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 664 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stage 2 Diastolic Hypertension appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.

NCT01218100 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT01218100 about?

NCT01218100 is a clinical study titled "Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension". This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).

What is the current status of trial NCT01218100?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 664 participants. The study started on 2010-10. Estimated completion is 2011-06.

What conditions does trial NCT01218100 study?

This clinical trial studies the following conditions: Stage 2 Diastolic Hypertension.

What interventions are being tested in trial NCT01218100?

The interventions under investigation include: placebo (DRUG), nebivolol and lisinopril (free combination) (DRUG), nebivolol monotherapy (DRUG), lisinopril monotherapy (DRUG).

Who is sponsoring clinical trial NCT01218100?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01218100 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.