Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01415531
Collaborator
(none)
641
75
2
8
8.5
1.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
641 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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
Study Start Date
:
Aug 1, 2011
Actual Primary Completion Date
:
Mar 1, 2012
Actual Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Trough Seated Diastolic Blood Pressure (DBP) [Change from Baseline to Week 8]
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) [Change from Baseline to Week 8]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 54 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forest Investigative Site 065 | Phoenix | Arizona | United States | 85014 |
| 2 | Forest Investigative Site 067 | Phoenix | Arizona | United States | 85014 |
| 3 | Forest Investigative Site 070 | Phoenix | Arizona | United States | 85014 |
| 4 | Forest Investigative Site 049 | Buena Park | California | United States | 90620 |
| 5 | Forest Investigative Site 034 | Burbank | California | United States | 91505 |
| 6 | Forest Investigative Site 039 | Costa Mesa | California | United States | 92626 |
| 7 | Forest Investigative Site 024 | Fountain Valley | California | United States | 92708 |
| 8 | Forest Investigative Site 020 | Fresno | California | United States | 93726 |
| 9 | Forest Investigative Site 021 | Fresno | California | United States | 93726 |
| 10 | Forest Investigative Site 040 | Greenbrae | California | United States | 94904 |
| 11 | Forest Investigative Site 047 | La Mesa | California | United States | 91942 |
| 12 | Forest Investigative Site 073 | Los Angeles | California | United States | 90057 |
| 13 | Forest Investigative Site 077 | Roseville | California | United States | 95661 |
| 14 | Forest Investigative Site 060 | San Bernardino | California | United States | 92404 |
| 15 | Forest Investigative Site 054 | San Francisco | California | United States | 94115 |
| 16 | Forest Investigative Site 018 | Spring Valley | California | United States | 91978 |
| 17 | Forest Investigative Site 028 | Denver | Colorado | United States | 80220 |
| 18 | Forest Investigative Site 059 | Brooksville | Florida | United States | 34601 |
| 19 | Forest Investigative Site 033 | Ft. Lauderdale | Florida | United States | 33306 |
| 20 | Forest Investigative Site 006 | Hallandale Beach | Florida | United States | 33009 |
| 21 | Forest Investigative Site 044 | Longwood | Florida | United States | 32779 |
| 22 | Forest Investigative Site 001 | Miami | Florida | United States | 33014 |
| 23 | Forest Investigative Site 012 | Miami | Florida | United States | 33014 |
| 24 | Forest Investigative Site 032 | Miami | Florida | United States | 33014 |
| 25 | Forest Investigative Site 055 | Miami | Florida | United States | 33014 |
| 26 | Forest Investigative Site 045 | Oviedo | Florida | United States | 32765 |
| 27 | Forest Investigative Site 031 | St. Petersburg | Florida | United States | 33709 |
| 28 | Forest Investigative Site 009 | Atlanta | Georgia | United States | 30084 |
| 29 | Forest Investigative Site 007 | Chicago | Illinois | United States | 60611 |
| 30 | Forest Investigative Site 004 | Morton | Illinois | United States | 61550 |
| 31 | Forest Investigative Site 072 | Evansville | Indiana | United States | 47713 |
| 32 | Forest Investigative Site 069 | Newburgh | Indiana | United States | 47630 |
| 33 | Forest Investigative Site 025 | Augusta | Kansas | United States | 67010 |
| 34 | Forest Investigative Site 029 | Louisville | Kentucky | United States | 40213 |
| 35 | Forest Investigative Site 068 | Madisonville | Kentucky | United States | 42431 |
| 36 | Forest Investigative Site 061 | Metairie | Louisiana | United States | 70005 |
| 37 | Forest Investigative Site 057 | New Orleans | Louisiana | United States | 70119 |
| 38 | Forest Investigative Site 058 | New Orleans | Louisiana | United States | 70119 |
| 39 | Forest Investigative Site 008 | Lutherville | Maryland | United States | 21093 |
| 40 | Forest Investigative Site 062 | Fall River | Massachusetts | United States | 02702 |
| 41 | Forest Investigative Site 075 | Paw Paw | Michigan | United States | 49079 |
| 42 | Forest Investigative Site 019 | Brooklyn Center | Minnesota | United States | 55430 |
| 43 | Forest Investigative Site 017 | Chaska | Minnesota | United States | 55318 |
| 44 | Forest Investigative Site 038 | Belzoni | Mississippi | United States | 39038 |
| 45 | Forest Investigative Site 035 | Olive Branch | Mississippi | United States | 38654 |
| 46 | Forest Investigative Site 023 | Las Vegas | Nevada | United States | 89101 |
| 47 | Forest Investigative Site 048 | Las Vegas | Nevada | United States | 89101 |
| 48 | Forest Investigative Site 052 | Las Vegas | Nevada | United States | 89101 |
| 49 | Forest Investigative Site 014 | Elizabeth | New Jersey | United States | 27609 |
| 50 | Forest Investigative Site 051 | Trenton | New Jersey | United States | 08611 |
| 51 | Forest Investigative Site 003 | Asheboro | North Carolina | United States | 27203 |
| 52 | Forest Investigative Site 010 | Charlotte | North Carolina | United States | 28277 |
| 53 | Forest Investigative Site 011 | Raleigh | North Carolina | United States | 27609 |
| 54 | Forest Investigative Site 016 | Raleigh | North Carolina | United States | 27609 |
| 55 | Forest Investigative Site 005 | Wilmington | North Carolina | United States | 28401 |
| 56 | Forest Investigative Site 036 | Winston-Salem | North Carolina | United States | 27103 |
| 57 | Forest Investigative Site 002 | Columbus | Ohio | United States | 43213 |
| 58 | Forest Investigative Site 050 | Norman | Oklahoma | United States | 73069 |
| 59 | Forest Investigative Site 030 | Portland | Oregon | United States | 33709 |
| 60 | Forest Investigative Site 056 | Downingtown | Pennsylvania | United States | 19335 |
| 61 | Forest Investigative Site 022 | Pelzer | South Carolina | United States | 29669 |
| 62 | Forest Investigative Site 053 | Beaumont | Texas | United States | 77701 |
| 63 | Forest Investigative Site 066 | Boerne | Texas | United States | 78006 |
| 64 | Forest Investigative Site 076 | Corpus Christi | Texas | United States | 78404 |
| 65 | Forest Investigative Site 037 | Dallas | Texas | United States | 75234 |
| 66 | Forest Investigative Site 043 | Haltom City | Texas | United States | 84070 |
| 67 | Forest Investigative Site 015 | Houston | Texas | United States | 77081 |
| 68 | Forest Investigative Site 026 | Houston | Texas | United States | 77081 |
| 69 | Forest Investigative Site 027 | Houston | Texas | United States | 77081 |
| 70 | Forest Investigative Site 074 | Houston | Texas | United States | 77081 |
| 71 | Forest Investigative Site 071 | Orem | Utah | United States | 84058 |
| 72 | Forest Investigative Site 042 | Sandy | Utah | United States | 84070 |
| 73 | Forest Investigative Site 063 | Norfolk | Virginia | United States | 23502 |
| 74 | Forest Investigative Site 064 | Norfolk | Virginia | United States | 23502 |
| 75 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415531
Other Study ID Numbers:
- NEB-MD-28
First Posted:
Aug 12, 2011
Last Update Posted:
May 16, 2013
Last Verified:
Mar 1, 2013
Keywords provided by Forest Laboratories
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Nebivolol |
|---|---|---|
| Arm/Group Description | Dose-matched placebo | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration |
| Period Title: Overall Study | ||
| STARTED | 214 | 427 |
| COMPLETED | 189 | 390 |
| NOT COMPLETED | 25 | 37 |
Baseline Characteristics
| Arm/Group Title | Placebo | Nebivolol | Total |
|---|---|---|---|
| Arm/Group Description | Dose-matched placebo | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration | Total of all reporting groups |
| Overall Participants | 214 | 427 | 641 |
| Age (years) [Mean (Standard Deviation) ] | |||
| 18 to 54 |
46.0
(6.9)
|
44.9
(6.9)
|
45.3
(6.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
95
44.4%
|
190
44.5%
|
285
44.5%
|
| Male |
119
55.6%
|
237
55.5%
|
356
55.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
214
100%
|
427
100%
|
641
100%
|
Outcome Measures
| Title | Trough Seated Diastolic Blood Pressure (DBP) |
|---|---|
| Description | 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. |
| Time Frame | Change from Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment |
| Arm/Group Title | Placebo | Nebivolol |
|---|---|---|
| Arm/Group Description | Dose-matched placebo | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration |
| Measure Participants | 211 | 423 |
| Mean (Standard Deviation) [mmHG] |
-5.5
(9.5)
|
-11.8
(8.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Nebivolol |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -6.3 | |
| Confidence Interval |
(2-Sided) 95% -7.7 to -4.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Trough Seated Systolic Blood Pressure (SBP) |
|---|---|
| Description | 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. |
| Time Frame | Change from Baseline to Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment |
| Arm/Group Title | Placebo | Nebivolol |
|---|---|---|
| Arm/Group Description | Dose-matched placebo | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration |
| Measure Participants | 211 | 423 |
| Mean (Standard Deviation) [mm Hg] |
-5.5
(13.9)
|
-13.7
(14.5)
|
Adverse Events
| Time Frame | Adverse event data was collected over a 9 month period from August of 2011 to April of 2012 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment. | |||
| Arm/Group Title | Placebo | Nebivolol | ||
| Arm/Group Description | Dose-matched placebo | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration | ||
All Cause Mortality |
||||
| Placebo | Nebivolol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo | Nebivolol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/214 (1.9%) | 4/427 (0.9%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/214 (0%) | 1/427 (0.2%) | ||
| General disorders | ||||
| Non-cardiac chest pain | 1/214 (0.5%) | 0/427 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 0/214 (0%) | 1/427 (0.2%) | ||
| Injury, poisoning and procedural complications | ||||
| Toxicity to various agents | 0/214 (0%) | 1/427 (0.2%) | ||
| Fall | 1/214 (0.5%) | 0/427 (0%) | ||
| Splenic rupture | 1/214 (0.5%) | 0/427 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Prostate cancer | 1/214 (0.5%) | 0/427 (0%) | ||
| Nervous system disorders | ||||
| Transient ischaemic attack | 1/214 (0.5%) | 0/427 (0%) | ||
| Reproductive system and breast disorders | ||||
| Vaginal haemorrhage | 0/214 (0%) | 1/427 (0.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Nebivolol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/214 (9.8%) | 37/427 (8.7%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 4/214 (1.9%) | 23/427 (5.4%) | ||
| Nervous system disorders | ||||
| Headache | 17/214 (7.9%) | 14/427 (3.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc
Results Point of Contact
| Name/Title | Tatjana Lukic, MD, MSc |
|---|---|
| Organization | Forest Research Institute |
| Phone | (201) 427-8649 |
| tanya.lukic@frx.com |
Responsible Party:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415531
Other Study ID Numbers:
- NEB-MD-28
First Posted:
Aug 12, 2011
Last Update Posted:
May 16, 2013
Last Verified:
Mar 1, 2013