Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
NCT01218100 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 664 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01218100
The ClinicalTrials.gov registry entry for NCT01218100 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 664 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 Stage 2 Diastolic Hypertension appearing as the primary indexed condition, and to 4 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: NCT01218100 reports 20 study locations spanning 5 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01218100?
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 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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.