Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415531
First received: August 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nebivolol Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Trough Seated Diastolic Blood Pressure (DBP) [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Secondary Outcome Measures:
- Trough Seated Systolic Blood Pressure (SBP) [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
| Enrollment: | 641 |
| Study Start Date: | August 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
Drug: Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|
Placebo Comparator: 2
Dose-matched placebo
|
Drug: Placebo
Dose-match placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 54 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female outpatients, of age 18 - 54 years
- Patients diagnosed with stage 1 or stage 2 essential hypertension
- Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant
Exclusion Criteria:
- Secondary hypertension or severe hypertension
- History of Type 1 diabetes mellitus
- A medical contraindication to discontinuing a current antihypertensive therapy
- Clinically significant respiratory disease that prohibit use of a beta blocker
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415531
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| United States, Arizona | |
| Forest Investigative Site 065 | |
| Phoenix, Arizona, United States, 85014 | |
| Forest Investigative Site 067 | |
| Phoenix, Arizona, United States, 85014 | |
| Forest Investigative Site 070 | |
| Phoenix, Arizona, United States, 85014 | |
| United States, California | |
| Forest Investigative Site 049 | |
| Buena Park, California, United States, 90620 | |
| Forest Investigative Site 034 | |
| Burbank, California, United States, 91505 | |
| Forest Investigative Site 039 | |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 024 | |
| Fountain Valley, California, United States, 92708 | |
| Forest Investigative Site 021 | |
| Fresno, California, United States, 93726 | |
| Forest Investigative Site 020 | |
| Fresno, California, United States, 93726 | |
| Forest Investigative Site 040 | |
| Greenbrae, California, United States, 94904 | |
| Forest Investigative Site 047 | |
| La Mesa, California, United States, 91942 | |
| Forest Investigative Site 073 | |
| Los Angeles, California, United States, 90057 | |
| Forest Investigative Site 077 | |
| Roseville, California, United States, 95661 | |
| Forest Investigative Site 060 | |
| San Bernardino, California, United States, 92404 | |
| Forest Investigative Site 054 | |
| San Francisco, California, United States, 94115 | |
| Forest Investigative Site 018 | |
| Spring Valley, California, United States, 91978 | |
| United States, Colorado | |
| Forest Investigative Site 028 | |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| Forest Investigative Site 059 | |
| Brooksville, Florida, United States, 34601 | |
| Forest Investigative Site 033 | |
| Ft. Lauderdale, Florida, United States, 33306 | |
| Forest Investigative Site 006 | |
| Hallandale Beach, Florida, United States, 33009 | |
| Forest Investigative Site 044 | |
| Longwood, Florida, United States, 32779 | |
| Forest Investigative Site 012 | |
| Miami, Florida, United States, 33014 | |
| Forest Investigative Site 055 | |
| Miami, Florida, United States, 33014 | |
| Forest Investigative Site 032 | |
| Miami, Florida, United States, 33014 | |
| Forest Investigative Site 001 | |
| Miami, Florida, United States, 33014 | |
| Forest Investigative Site 045 | |
| Oviedo, Florida, United States, 32765 | |
| Forest Investigative Site 031 | |
| St. Petersburg, Florida, United States, 33709 | |
| United States, Georgia | |
| Forest Investigative Site 009 | |
| Atlanta, Georgia, United States, 30084 | |
| United States, Illinois | |
| Forest Investigative Site 007 | |
| Chicago, Illinois, United States, 60611 | |
| Forest Investigative Site 004 | |
| Morton, Illinois, United States, 61550 | |
| United States, Indiana | |
| Forest Investigative Site 072 | |
| Evansville, Indiana, United States, 47713 | |
| Forest Investigative Site 069 | |
| Newburgh, Indiana, United States, 47630 | |
| United States, Kansas | |
| Forest Investigative Site 025 | |
| Augusta, Kansas, United States, 67010 | |
| United States, Kentucky | |
| Forest Investigative Site 029 | |
| Louisville, Kentucky, United States, 40213 | |
| Forest Investigative Site 068 | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Forest Investigative Site 061 | |
| Metairie, Louisiana, United States, 70005 | |
| Forest Investigative Site 058 | |
| New Orleans, Louisiana, United States, 70119 | |
| Forest Investigative Site 057 | |
| New Orleans, Louisiana, United States, 70119 | |
| United States, Maryland | |
| Forest Investigative Site 008 | |
| Lutherville, Maryland, United States, 21093 | |
| United States, Massachusetts | |
| Forest Investigative Site 062 | |
| Fall River, Massachusetts, United States, 02702 | |
| United States, Michigan | |
| Forest Investigative Site 075 | |
| Paw Paw, Michigan, United States, 49079 | |
| United States, Minnesota | |
| Forest Investigative Site 019 | |
| Brooklyn Center, Minnesota, United States, 55430 | |
| Forest Investigative Site 017 | |
| Chaska, Minnesota, United States, 55318 | |
| United States, Mississippi | |
| Forest Investigative Site 038 | |
| Belzoni, Mississippi, United States, 39038 | |
| Forest Investigative Site 035 | |
| Olive Branch, Mississippi, United States, 38654 | |
| United States, Nevada | |
| Forest Investigative Site 023 | |
| Las Vegas, Nevada, United States, 89101 | |
| Forest Investigative Site 048 | |
| Las Vegas, Nevada, United States, 89101 | |
| Forest Investigative Site 052 | |
| Las Vegas, Nevada, United States, 89101 | |
| United States, New Jersey | |
| Forest Investigative Site 014 | |
| Elizabeth, New Jersey, United States, 27609 | |
| Forest Investigative Site 051 | |
| Trenton, New Jersey, United States, 08611 | |
| United States, North Carolina | |
| Forest Investigative Site 003 | |
| Asheboro, North Carolina, United States, 27203 | |
| Forest Investigative Site 010 | |
| Charlotte, North Carolina, United States, 28277 | |
| Forest Investigative Site 011 | |
| Raleigh, North Carolina, United States, 27609 | |
| Forest Investigative Site 016 | |
| Raleigh, North Carolina, United States, 27609 | |
| Forest Investigative Site 005 | |
| Wilmington, North Carolina, United States, 28401 | |
| Forest Investigative Site 036 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Forest Investigative Site 002 | |
| Columbus, Ohio, United States, 43213 | |
| United States, Oklahoma | |
| Forest Investigative Site 050 | |
| Norman, Oklahoma, United States, 73069 | |
| United States, Oregon | |
| Forest Investigative Site 030 | |
| Portland, Oregon, United States, 33709 | |
| United States, Pennsylvania | |
| Forest Investigative Site 056 | |
| Downingtown, Pennsylvania, United States, 19335 | |
| United States, South Carolina | |
| Forest Investigative Site 022 | |
| Pelzer, South Carolina, United States, 29669 | |
| United States, Texas | |
| Forest Investigative Site 053 | |
| Beaumont, Texas, United States, 77701 | |
| Forest Investigative Site 066 | |
| Boerne, Texas, United States, 78006 | |
| Forest Investigative Site 076 | |
| Corpus Christi, Texas, United States, 78404 | |
| Forest Investigative Site 037 | |
| Dallas, Texas, United States, 75234 | |
| Forest Investigative Site 043 | |
| Haltom City, Texas, United States, 84070 | |
| Forest Investigative Site 026 | |
| Houston, Texas, United States, 77081 | |
| Forest Investigative Site 027 | |
| Houston, Texas, United States, 77081 | |
| Forest Investigative Site 074 | |
| Houston, Texas, United States, 77081 | |
| Forest Investigative Site 015 | |
| Houston, Texas, United States, 77081 | |
| United States, Utah | |
| Forest Investigative Site 071 | |
| Orem, Utah, United States, 84058 | |
| Forest Investigative Site 042 | |
| Sandy, Utah, United States, 84070 | |
| United States, Virginia | |
| Forest Investigative Site 063 | |
| Norfolk, Virginia, United States, 23502 | |
| Forest Investigative Site 064 | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Forest Investigative Site 046 | |
| Port Orchard, Washington, United States, 98366 | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Tatjana Lukic, MD, M. Sc. | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01415531 History of Changes |
| Other Study ID Numbers: | NEB-MD-28 |
| Study First Received: | August 10, 2011 |
| Results First Received: | March 18, 2013 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Forest Laboratories:
|
Stage 1 Stage 2 Hypertension |
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