A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
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Purpose
The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nebivolol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension |
- The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.
- Change in the average
- - sitting systolic blood pressure
- - supine and standing systolic and diastolic blood pressure
- - response rate of treatment groups
- - AEs
- - ECGs
- - laboratory parameters
- - heart rate
| Estimated Enrollment: | 845 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | September 2003 |
This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.
Exclusion Criteria:
- Secondary hypertension
- myocardial infarction or stroke
- contraindications to beta-blocker therapy
Contacts and Locations| United States, West Virginia | |
| Mylan Pharmaceuticals Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Study Director: | Betty S. Riggs, MD, MBA | Mylan Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00200499 History of Changes |
| Other Study ID Numbers: | NEB306 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 15, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mylan Bertek Pharmaceuticals:
|
Nebivolol Hypertension Beta-Blocker |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Nebivolol Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Vasodilator Agents Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013