Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01415505
Collaborator
(none)
812
135
1
20
6
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
812 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension
Study Start Date
:
Aug 1, 2011
Actual Primary Completion Date
:
Jan 1, 2013
Actual Study Completion Date
:
Apr 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1 Nebivolol and Valsartan free tablet combination |
Drug: Nebivolol, Valsartan and Hydrochlorothiazide
Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration
|
Outcome Measures
Primary Outcome Measures
- Adverse Event Recording [From Baseline to Week 53 (Visit 16)]
Secondary Outcome Measures
- Diastolic Blood Pressure (DBP). [From Baseline to Week 52 (Visit 15)]
- Systolic Blood Pressure (SBP) [From Baseline to Week 52 (Visit 15)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female outpatients of age 18 years or above
-
Patients diagnosed with stage 1 or stage 2 essential hypertension
-
Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant
Exclusion Criteria:
-
Secondary hypertension or severe hypertension
-
Clinically significant cardiovascular disease or heart failure
-
A medical contraindication to discontinuing a current antihypertensive therapy
-
History of Type 1 diabetes mellitus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forest Investigative Site 083 | Birmingham | Alabama | United States | 35216 |
| 2 | Forest Investigative Site 004 | Foley | Alabama | United States | 36535 |
| 3 | Forest Investigative Site 038 | Gulf Shores | Alabama | United States | 36542 |
| 4 | Forest Investigative Site 124 | Muscle Shoals | Alabama | United States | 35662 |
| 5 | Forest Investigative Site 023 | Chandler | Arizona | United States | 85224 |
| 6 | Forest Investigative Site 073 | Goodyear | Arizona | United States | 85395 |
| 7 | Forest Investigative Site 100 | Green Valley | Arizona | United States | 85614 |
| 8 | Forest Investigative Site 117 | Mesa | Arizona | United States | 85203 |
| 9 | Forest Investigative Site 065 | Mesa | Arizona | United States | 85213 |
| 10 | Forest Investigative Site 102 | Phoenix | Arizona | United States | 85020 |
| 11 | Forest Investigative Site 103 | Tempe | Arizona | United States | 85282 |
| 12 | Forest Investigative Site 068 | Tempe | Arizona | United States | 85283 |
| 13 | Forest Investigative Site 066 | Jonesboro | Arkansas | United States | 72401 |
| 14 | Forest Investigative Site 118 | Jonesboro | Arkansas | United States | 72401 |
| 15 | Forest Investigative Site 135 | Carmichael | California | United States | 95608 |
| 16 | Forest Investigative Site 064 | Encinitas | California | United States | 92024 |
| 17 | Forest Investigative Site 046 | Encino | California | United States | 91436 |
| 18 | Forest Investigative Site 098 | Glendale | California | United States | 91205 |
| 19 | Forest Investigative Site 129 | Huntington Park | California | United States | 90255-5835 |
| 20 | Forest Investigative Site 136 | Lancaster | California | United States | 93534 |
| 21 | Forest Investigative Site 096 | Long Beach | California | United States | 90806 |
| 22 | Forest Investigative Site 015 | Los Angeles | California | United States | 90036 |
| 23 | Forest Investigative Site 025 | Los Angeles | California | United States | 90057 |
| 24 | Forest Investigative Site 101 | Mission Hills | California | United States | 91345 |
| 25 | Forest Investigative Site 089 | Palm Springs | California | United States | 92262 |
| 26 | Forest Investigative Site 116 | Pismo Beach | California | United States | 93449 |
| 27 | Forest Investigative Site 138 | Sacramento | California | United States | 95816 |
| 28 | Forest Investigative Site 132 | San Diego | California | United States | 92111 |
| 29 | Forest Investigative Site 061 | San Marino | California | United States | 91108 |
| 30 | Forest Investigative Site 095 | San Ramon | California | United States | 94583 |
| 31 | Forest Investigative Site 087 | Santa Ana | California | United States | 92701 |
| 32 | Forest Investigative Site 134 | Santa Barbara | California | United States | 93110 |
| 33 | Forest Investigative Site 062 | Tustin | California | United States | 92780 |
| 34 | Forest Investigative Site 130 | Tustin | California | United States | 92780 |
| 35 | Forest Investigative Site 092 | West Hills | California | United States | 91307 |
| 36 | Forest Investigative Site 028 | Westlake Village | California | United States | 91361 |
| 37 | Forest Investigative Site 006 | Northglenn | Colorado | United States | 80234 |
| 38 | Forest Investigative Site 030 | Cromwell | Connecticut | United States | 06416 |
| 39 | Forest Investigative Site 018 | Waterbury | Connecticut | United States | 06708 |
| 40 | Forest Investigative Site 106 | Boca Raton | Florida | United States | 33432 |
| 41 | Forest Investigative Site 044 | Brooksville | Florida | United States | 34601 |
| 42 | Forest Investigative Site 049 | Coral Gables | Florida | United States | 33134 |
| 43 | Forest Investigative Site 069 | Cutler Bay | Florida | United States | 33189 |
| 44 | Forest Investigative Site 059 | Daytona Beach | Florida | United States | 32114 |
| 45 | Forest Investigative Site 048 | Fort Lauderdale | Florida | United States | 33306 |
| 46 | Forest Investigative Site 001 | Fort Lauderdale | Florida | United States | 33308 |
| 47 | Forest Investigative Site 002 | Hialeah | Florida | United States | 33012 |
| 48 | Forest Investigative Site 022 | Miami | Florida | United States | 33143 |
| 49 | Forest Investigative Site 032 | Miami | Florida | United States | 33183 |
| 50 | Forest Investigative Site 005 | New Port Richey | Florida | United States | 34652 |
| 51 | Forest Investigative Site 021 | North Miami Beach | Florida | United States | 33162 |
| 52 | Forest Investigative Site 111 | Ocala | Florida | United States | 34471 |
| 53 | Forest Investigative Site 056 | Pembroke Pines | Florida | United States | 33024 |
| 54 | Forest Investigative Site 127 | Pembroke Pines | Florida | United States | 33026 |
| 55 | Forest Investigative Site 054 | Pembroke Pines | Florida | United States | 33028 |
| 56 | Forest Investigative Site 133 | Pembroke Pines | Florida | United States | 33029 |
| 57 | Forest Investigative Site 085 | Plant City | Florida | United States | 33563 |
| 58 | Forest Investigative Site 033 | Tampa | Florida | United States | 33606 |
| 59 | Forest Investigative Site 008 | Winter Haven | Florida | United States | 33880 |
| 60 | Forest Investigative Site 019 | Atlanta | Georgia | United States | 30338 |
| 61 | Forest Investigative Site 077 | Roswell | Georgia | United States | 30076 |
| 62 | Forest Investigative Site 126 | Arlington Heights | Illinois | United States | 60004 |
| 63 | Forest Investigative Site 084 | Chicago | Illinois | United States | 60607 |
| 64 | Forest Investigative Site 088 | Evansville | Indiana | United States | 47710 |
| 65 | Forest Investigative Site 108 | Newton | Kansas | United States | 67114 |
| 66 | Forest Investigative Site 050 | Lexington | Kentucky | United States | 40504 |
| 67 | Forest Investigative Site 003 | Madisonville | Kentucky | United States | 42431 |
| 68 | Forest Investigative Site 141 | Metairie | Louisiana | United States | 70002 |
| 69 | Forest Investigative Site 057 | Auburn | Maine | United States | 04210 |
| 70 | Forest Investigative Site 041 | Baltimore | Maryland | United States | 21209 |
| 71 | Forest Investigative Site 014 | Baltimore | Maryland | United States | 21236 |
| 72 | Forest Investigative Site 080 | Elkridge | Maryland | United States | 21075 |
| 73 | Forest Investigative Site 017 | Haverhill | Massachusetts | United States | 01830 |
| 74 | Forest Investigative Site 143 | Kalamazoo | Michigan | United States | 49009 |
| 75 | Forest Investigative Site 071 | Troy | Michigan | United States | 48085 |
| 76 | Forest Investigative Site 086 | Jackson | Mississippi | United States | 39209 |
| 77 | Forest Investigative Site 099 | Omaha | Nebraska | United States | 68134 |
| 78 | Forest Investigative Site 120 | Las Vegas | Nevada | United States | 89106 |
| 79 | Forest Investigative Site 119 | Las Vegas | Nevada | United States | 89119 |
| 80 | Forest Investigative Site 121 | Las Vegas | Nevada | United States | 89148 |
| 81 | Forest Investigative Site 137 | Berkeley Heights | New Jersey | United States | 07922 |
| 82 | Forest Investigative Site 047 | Binghamton | New York | United States | 13901 |
| 83 | Forest Investigative Site 072 | Rosedale | New York | United States | 11422 |
| 84 | Forest Investigative Site 128 | Saratoga Springs | New York | United States | 12866 |
| 85 | Forest Investigative Site 042 | Charlotte | North Carolina | United States | 28209 |
| 86 | Forest Investigative Site 139 | Greensboro | North Carolina | United States | 27401 |
| 87 | Forest Investigative Site 007 | Hickory | North Carolina | United States | 28602 |
| 88 | Forest Investigative Site 114 | Lenoir | North Carolina | United States | 28645 |
| 89 | Forest Investigative Site 081 | Salisbury | North Carolina | United States | 28144 |
| 90 | Forest Investigative Site 013 | Shelby | North Carolina | United States | 28150 |
| 91 | Forest Investigative Site 011 | Wilmington | North Carolina | United States | 28401 |
| 92 | Forest Investigative Site 036 | Winston-Salem | North Carolina | United States | 27103 |
| 93 | Forest Investigative Site 009 | Cincinnati | Ohio | United States | 45242 |
| 94 | Forest Investigative Site 125 | Kettering | Ohio | United States | 45212 |
| 95 | Forest Investigative Site 094 | Marion | Ohio | United States | 43302 |
| 96 | Forest Investigative Site 093 | Mount Gilead | Ohio | United States | 43338 |
| 97 | Forest Investigative Site 112 | Oklahoma City | Oklahoma | United States | 73103 |
| 98 | Forest Investigative Site 104 | Eugene | Oregon | United States | 97404 |
| 99 | Forest Investigative Site 058 | Beaver | Pennsylvania | United States | 15009 |
| 100 | Forest Investigative Site 131 | Penndel | Pennsylvania | United States | 19047 |
| 101 | Forest Investigative Site 105 | Philadelphia | Pennsylvania | United States | 19146 |
| 102 | Forest Investigative Site 039 | Upper St. Clair | Pennsylvania | United States | 15241 |
| 103 | Forest Investigative Site 012 | Charleston | South Carolina | United States | 29407 |
| 104 | Forest Investigative Site 040 | Columbia | South Carolina | United States | 29204 |
| 105 | Forest Investigative Site 060 | Greer | South Carolina | United States | 29651 |
| 106 | Forest Investigative Site 035 | Mt. Pleasant | South Carolina | United States | 29464 |
| 107 | Forest Investigative Site 082 | Mt. Pleasant | South Carolina | United States | 29464 |
| 108 | Forest Investigative Site 142 | Simpsonville | South Carolina | United States | 29681 |
| 109 | Forest Investigative Site 045 | Summerville | South Carolina | United States | 29485 |
| 110 | Forest Investigative Site 113 | Bristol | Tennessee | United States | 37620 |
| 111 | Forest Investigative Site 034 | Fayetteville | Tennessee | United States | 37334 |
| 112 | Forest Investigative Site 070 | Franklin | Tennessee | United States | 37067 |
| 113 | Forest Investigative Site 016 | Arlington | Texas | United States | 76012 |
| 114 | Forest Investigative Site 063 | Carrollton | Texas | United States | 75006 |
| 115 | Forest Investigative Site 123 | Dallas | Texas | United States | 75251 |
| 116 | Forest Investigative Site 079 | Fort Worth | Texas | United States | 76135 |
| 117 | Forest Investigative Site 052 | Houston | Texas | United States | 77079 |
| 118 | Forest Investigative Site 024 | Houston | Texas | United States | 77081 |
| 119 | Forest Investigative Site 026 | Houston | Texas | United States | 77081 |
| 120 | Forest Investigative Site 027 | Houston | Texas | United States | 77081 |
| 121 | Forest Investigative Site 140 | Plano | Texas | United States | 75075 |
| 122 | Forest Investigative Site 091 | San Angelo | Texas | United States | 76904 |
| 123 | Forest Investigative Site 055 | San Antonio | Texas | United States | 78209 |
| 124 | Forest Investigative Site 115 | San Antonio | Texas | United States | 78229 |
| 125 | Forest Investigative Site 078 | Sugar Land | Texas | United States | 77479 |
| 126 | Forest Investigative Site 090 | Salt Lake City | Utah | United States | 84107 |
| 127 | Forest Investigative Site 053 | Salt Lake City | Utah | United States | 84124 |
| 128 | Forest Investigative Site 051 | St. George | Utah | United States | 84790 |
| 129 | Forest Investigative Site 110 | Alexandria | Virginia | United States | 22304 |
| 130 | Forest Investigative Site 074 | Burke | Virginia | United States | 22015 |
| 131 | Forest Investigative Site 067 | Manassas | Virginia | United States | 20110 |
| 132 | Forest Investigative Site 037 | Norfolk | Virginia | United States | 23507 |
| 133 | Forest Investigative Site 122 | Suffolk | Virginia | United States | 23435 |
| 134 | Forest Investigative Site 010 | Virginia Beach | Virginia | United States | 23454 |
| 135 | Forest Investigative Site 107 | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Forest Laboratories
Investigators
- Study Director: David B Bharucha, MD, PhD, FACC, Forest Laboratories
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415505
Other Study ID Numbers:
- NAC-MD-02
First Posted:
Aug 12, 2011
Last Update Posted:
Jun 4, 2013
Last Verified:
May 1, 2013
Keywords provided by Forest Laboratories
Additional relevant MeSH terms: