Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01508026
First received: January 9, 2012
Last updated: May 31, 2013
Last verified: May 2013
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Purpose
To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage 1 Hypertension Stage 2 Hypertension |
Drug: Nebivolol and Valsartan 1 Drug: Nebivolol and Valsartan 2 Drug: Nebivolol and Valsartan 3 Drug: Nebivolol 1 Drug: Nebivolol 2 Drug: Valsartan 1 Drug: Valsartan 2 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Change in Sitting Diastolic Blood Pressure (DBP) [ Time Frame: from basline to Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Sitting Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
| Enrollment: | 4161 |
| Study Start Date: | January 2012 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nebivolol and Valsartan Fixed Dose Combination 1
Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
|
Drug: Nebivolol and Valsartan 1
Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
|
|
Experimental: Nebivolol and Valsartan Fixed Dose Combination 2
Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg
|
Drug: Nebivolol and Valsartan 2
Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
|
|
Experimental: Nebivolol and Valsartan Fixed Dose Combination 3
Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
|
Drug: Nebivolol and Valsartan 3
Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
|
|
Experimental: Nebivolol Low Dose
Nebivolol Monotherapy 5 mg
|
Drug: Nebivolol 1
Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
|
|
Experimental: Nebivolol High Dose
Nebivolol Monotherapy 20 mg
|
Drug: Nebivolol 2
Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
|
|
Experimental: Valsartan Low Dose
Valsartan Monotherapy 80 mg
|
Drug: Valsartan 1
Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
|
|
Experimental: Valsartan High Dose
Valsartan Monotherapy 160 mg
|
Drug: Valsartan 2
Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
|
|
Placebo Comparator: Placebo
Dose Matched placebo
|
Drug: Placebo
Dose matched placebo, oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
- Clinical significant respiratory disease that would prohibit the use of a beta blocker
- A medical contraindication to discontinuing a current antihypertensive therapy
- History of Type 1 diabetes mellitus
- History of Severe Mental Illness except mild depression
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508026
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| United States, Alabama | |
| Forest Investigative Site 1192 | |
| Birmingham, Alabama, United States, 35242 | |
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| Birmingham, Alabama, United States, 35235 | |
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| Birmingham, Alabama, United States, 35216 | |
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| Birmingham, Alabama, United States, 35235 | |
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| Birmingham, Alabama, United States, 35294 | |
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| Foley, Alabama, United States, 36535 | |
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| Gulf Shores, Alabama, United States, 36542 | |
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| Mobile, Alabama, United States, 36617 | |
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| Muscle Shoals, Alabama, United States, 35662 | |
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| Glendale, Arizona, United States, 85308 | |
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| Goodyear, Arizona, United States, 85395 | |
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| Mesa, Arizona, United States, 85202 | |
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| Phoenix, Arizona, United States, 85050 | |
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| San Francisco, California, United States, 94115 | |
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| Colorado Springs, Colorado, United States, 80904 | |
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| Denver, Colorado, United States, 80220 | |
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| Denver, Colorado, United States, 80209 | |
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| Thornton, Colorado, United States, 80233 | |
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| Cromwell, Connecticut, United States, 06416 | |
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| Waterbury, Connecticut, United States, 06708 | |
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| Boca Raton, Florida, United States, 33432 | |
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| Bradenton, Florida, United States, 34208 | |
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| Brandon, Florida, United States, 33511 | |
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| Brooksville, Florida, United States, 34601 | |
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| Clearwater, Florida, United States, 33756 | |
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| Coral Gables, Florida, United States, 33134 | |
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| Coral Gables, Florida, United States, 33134 | |
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| Cutler Bay, Florida, United States, 33189 | |
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| Daytona Beach, Florida, United States, 32117 | |
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| Deerfield Beach, Florida, United States, 33441 | |
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| DeFuniak Springs, Florida, United States, 32435 | |
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| Deland, Florida, United States, 32720 | |
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| Doral, Florida, United States, 33172 | |
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| Doral, Florida, United States, 33166 | |
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| Edgewater, Florida, United States, 32132 | |
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| Fort Lauderdale, Florida, United States, 33319 | |
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| Fort Lauderdale, Florida, United States, 33306 | |
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| Ft. Lauderdale, Florida, United States, 33308 | |
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| Gainsville, Florida, United States, 32605 | |
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| Hallandale Beach, Florida, United States, 33009 | |
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| Hialeah, Florida, United States, 33012 | |
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| Hialeah, Florida, United States, 33012 | |
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| Hollywood, Florida, United States, 33021 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Jacksonville, Florida, United States, 32223 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Jupiter, Florida, United States, 33458 | |
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| Kissimmee, Florida, United States, 34741 | |
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| Kissimmee, Florida, United States, 34741 | |
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| Miami, Florida, United States, 33143 | |
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| Miami, Florida, United States, 33185 | |
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| Miami, Florida, United States, 33125 | |
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| Miami, Florida, United States, 33169 | |
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| Miami, Florida, United States, 33183 | |
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| Miami, Florida, United States, 33136 | |
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| Miami, Florida, United States, 33014 | |
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| Miami, Florida, United States, 33144 | |
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| Miami, Florida, United States, 33135 | |
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| Miami, Florida, United States, 33155 | |
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| Miami, Florida, United States, 33186 | |
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| Miami Springs, Florida, United States, 33166 | |
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| New Port Richey, Florida, United States, 34652 | |
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| North Miami Beach, Florida, United States, 33162 | |
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| Oldsmar, Florida, United States, 34677 | |
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| Opa-Locka, Florida, United States, 33054 | |
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| Orlando, Florida, United States, 32822 | |
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| Orlando, Florida, United States, 32811 | |
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| Orlando, Florida, United States, 32806 | |
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| Ormond Beach, Florida, United States, 32174 | |
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| Oviedo, Florida, United States, 32765 | |
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| Palm Harbor, Florida, United States, 34684 | |
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| Pembroke Pines, Florida, United States, 33028 | |
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| Plant City, Florida, United States, 33563 | |
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| St. Petersburg, Florida, United States, 33701 | |
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| Tampa, Florida, United States, 33606 | |
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| Tampa, Florida, United States, 33607 | |
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| Winter Haven, Florida, United States, 33880 | |
| United States, Georgia | |
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| Atlanta, Georgia, United States, 30308 | |
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| Atlanta, Georgia, United States, 30338 | |
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| Blue Ridge, Georgia, United States, 30513 | |
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| Lilburn, Georgia, United States, 30047 | |
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| Marietta, Georgia, United States, 30066 | |
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| Marietta, Georgia, United States, 30060 | |
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| Oakwood, Georgia, United States, 30566 | |
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| Sandy Springs, Georgia, United States, 30328 | |
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| Savannah, Georgia, United States, 31419 | |
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| Snellville, Georgia, United States, 30078 | |
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| Stockbridge, Georgia, United States, 30281 | |
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| Woodstock, Georgia, United States, 30189 | |
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| Honolulu, Hawaii, United States, 96814 | |
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| Blackfoot, Idaho, United States, 83221 | |
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| Boise, Idaho, United States, 83704 | |
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| Meridian, Idaho, United States, 83646 | |
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| Addison, Illinois, United States, 60101 | |
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| Arlington Heights, Illinois, United States, 60004 | |
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| Chicago, Illinois, United States, 60611 | |
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| Chicago, Illinois, United States, 60616 | |
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| Chicago, Illinois, United States, 60607 | |
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| Hazel Crest, Illinois, United States, 60429 | |
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| Morton, Illinois, United States, 61550 | |
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| O'Fallon, Illinois, United States, 62269 | |
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| Evansville, Indiana, United States, 47710 | |
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| Lenexa, Kansas, United States, 66219 | |
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| Mission, Kansas, United States, 66202 | |
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| Newton, Kansas, United States, 67114 | |
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| New Orleans, Louisiana, United States, 70115 | |
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| Baltimore, Maryland, United States, 21209 | |
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| Haverhill, Massachusetts, United States, 01830 | |
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| Watertown, Massachusetts, United States, 02472-3930 | |
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| United States, Mississippi | |
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| Belzoni, Mississippi, United States, 39038 | |
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| Jackson, Mississippi, United States, 39289-1214 | |
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| Kansas City, Missouri, United States, 64111 | |
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| St. Louis, Missouri, United States, 63141 | |
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| Missoula, Montana, United States, 59808 | |
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| Bellevue, Nebraska, United States, 68005 | |
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| Fremont, Nebraska, United States, 68025-2300 | |
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| Fremont, Nebraska, United States, 68025 | |
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| Omaha, Nebraska, United States, 68114 | |
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| Omaha, Nebraska, United States, 68144 | |
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| Omaha, Nebraska, United States, 68134 | |
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| Omaha, Nebraska, United States, 68134 | |
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| Henderson, Nevada, United States, 89014 | |
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| Henderson, Nevada, United States, 89052 | |
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| Las Vegas, Nevada, United States, 89104 | |
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| Las Vegas, Nevada, United States, 89148 | |
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| Las Vegas, Nevada, United States, 89101 | |
| Forest Investigative Site 1807 | |
| Las Vegas, Nevada, United States, 89123 | |
| Forest Investigative Site 1376 | |
| Las Vegas, Nevada, United States, 89103 | |
| United States, New Jersey | |
| Forest Investigative Site 1709 | |
| Edison, New Jersey, United States, 08817 | |
| Forest Investigative Site 1132 | |
| Haddon Heights, New Jersey, United States, 08035 | |
| Forest Investigative Site 1141 | |
| Linden, New Jersey, United States, 07036 | |
| Forest Investigative Site 1227 | |
| Paramus, New Jersey, United States, 07652 | |
| Forest Investigative Site 1169 | |
| Trenton, New Jersey, United States, 08611 | |
| Forest Investigative Site 1338 | |
| Union, New Jersey, United States, 07083 | |
| United States, New Mexico | |
| Forest Investigative Site 1761 | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Forest Investigative Site 1796 | |
| Brooklyn, New York, United States, 11203 | |
| Forest Investigative Site 1151 | |
| Buffalo, New York, United States, 14215 | |
| Forest Investigative Site 1021 | |
| Glen Falls, New York, United States, 12801 | |
| Forest Investigative Site 1115 | |
| Rochester, New York, United States, 14609 | |
| United States, North Carolina | |
| Forest Investigative Site 1040 | |
| Asheboro, North Carolina, United States, 27203 | |
| Forest Investigative Site 1073 | |
| Burlington, North Carolina, United States, 27215 | |
| Forest Investigative Site 1142 | |
| Cary, North Carolina, United States, 27519 | |
| Forest Investigative Site 1067 | |
| Charlotte, North Carolina, United States, 28277 | |
| Forest Investigative Site 1733 | |
| Charlotte, North Carolina, United States, 28209 | |
| Forest Investigative Site 1342 | |
| Dunn, North Carolina, United States, 28334 | |
| Forest Investigative Site 1088 | |
| Greensboro, North Carolina, United States, 27401 | |
| Forest Investigative Site 1385 | |
| Greensboro, North Carolina, United States, 27408 | |
| Forest Investigative Site 1309 | |
| Greensboro, North Carolina, United States, 27410 | |
| Forest Investigative Site 1098 | |
| Hickory, North Carolina, United States, 28602 | |
| Forest Investigative Site 1306 | |
| Hickory, North Carolina, United States, 28601 | |
| Forest Investigative Site 1110 | |
| Lenoir, North Carolina, United States, 28645 | |
| Forest Investigative Site 1272 | |
| Mooresville, North Carolina, United States, 28117 | |
| Forest Investigative Site 1024 | |
| Raleigh, North Carolina, United States, 27609 | |
| Forest Investigative Site 1789 | |
| Raleigh, North Carolina, United States, 27612 | |
| Forest Investigative Site 1715 | |
| Salisbury, North Carolina, United States, 28144 | |
| Forest Investigative Site 1123 | |
| Shelby, North Carolina, United States, 28152 | |
| Forest Investigative Site 1705 | |
| Wilmington, North Carolina, United States, 28401 | |
| Forest Investigative Site 1081 | |
| Wilmington, North Carolina, United States, 28401 | |
| Forest Investigative Site 1405 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Forest Investigative Site 1778 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Forest Investigative Site 1319 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Forest Investigative Site 1203 | |
| Akron, Ohio, United States, 44311 | |
| Forest Investigative Site 1210 | |
| Canal Fulton, Ohio, United States, 44614 | |
| Forest Investigative Site 1798 | |
| Cincinnati, Ohio, United States, 45227 | |
| Forest Investigative Site 1050 | |
| Cincinnati, Ohio, United States, 45249 | |
| Forest Investigative Site 1012 | |
| Cincinnati, Ohio, United States, 45219 | |
| Forest Investigative Site 1721 | |
| Cincinnati, Ohio, United States, 45219 | |
| Forest Investigative Site 1062 | |
| Cincinnati, Ohio, United States, 45246 | |
| Forest Investigative Site 1280 | |
| Cincinnati, Ohio, United States, 45224 | |
| Forest Investigative Site 1732 | |
| Cincinnati, Ohio, United States, 45236 | |
| Forest Investigative Site 1718 | |
| Cincinnati, Ohio, United States, 45242 | |
| Forest Investigative Site 1084 | |
| Cleveland, Ohio, United States, 44122 | |
| Forest Investigative Site 1765 | |
| Columbus, Ohio, United States, 43213 | |
| Forest Investigative Site 1395 | |
| Columbus, Ohio, United States, 43214 | |
| Forest Investigative Site 1209 | |
| Delaware, Ohio, United States, 43015 | |
| Forest Investigative Site 1201 | |
| Lyndhurst, Ohio, United States, 44124 | |
| Forest Investigative Site 1246 | |
| Maumee, Ohio, United States, 43537 | |
| Forest Investigative Site 1135 | |
| Mt. Gilead, Ohio, United States, 43338 | |
| Forest Investigative Site 1322 | |
| Perrysburg, Ohio, United States, 43551 | |
| Forest Investigative Site 1231 | |
| Willoughby, Ohio, United States, 44094 | |
| Forest Investigative Site 1713 | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| Forest Investigative Site 1195 | |
| Norman, Oklahoma, United States, 73069 | |
| Forest Investigative Site 1184 | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Forest Investigative Site 1759 | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Forest Investigative Site 1305 | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Forest Investigative Site 1392 | |
| Yukon, Oklahoma, United States, 73099 | |
| United States, Oregon | |
| Forest Investigative Site 1116 | |
| Ashland, Oregon, United States, 97520 | |
| Forest Investigative Site 1780 | |
| Eugene, Oregon, United States, 97404 | |
| Forest Investigative Site 1379 | |
| Eugene, Oregon, United States, 97402 | |
| Forest Investigative Site 1108 | |
| Hillsboro, Oregon, United States, 97123-4147 | |
| Forest Investigative Site 1294 | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Forest Investigative Site 1109 | |
| Bensalem, Pennsylvania, United States, 19020 | |
| Forest Investigative Site 1291 | |
| Bensalem, Pennsylvania, United States, 19020 | |
| Forest Investigative Site 1090 | |
| Broomall, Pennsylvania, United States, 19008 | |
| Forest Investigative Site 1218 | |
| Carnegie, Pennsylvania, United States, 15106 | |
| Forest Investigative Site 1163 | |
| Downington, Pennsylvania, United States, 19335 | |
| Forest Investigative Site 1171 | |
| Erie, Pennsylvania, United States, 16509 | |
| Forest Investigative Site 1118 | |
| Erie, Pennsylvania, United States, 16508 | |
| Forest Investigative Site 1383 | |
| Holland, Pennsylvania, United States, 18966 | |
| Forest Investigative Site 1720 | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Forest Investigative Site 1207 | |
| Lansdale, Pennsylvania, United States, 19446 | |
| Forest Investigative Site 1314 | |
| Norristown, Pennsylvania, United States, 19401 | |
| Forest Investigative Site 1198 | |
| Penndel, Pennsylvania, United States, 19047 | |
| Forest Investigative Site 1293 | |
| Philadelphia, Pennsylvania, United States, 19152 | |
| Forest Investigative Site 1137 | |
| Pittsburgh, Pennsylvania, United States, 15216 | |
| Forest Investigative Site 1247 | |
| Red Lion, Pennsylvania, United States, 17356 | |
| Forest Investigative Site 1791 | |
| Tipton, Pennsylvania, United States, 16684 | |
| Forest Investigative Site 1196 | |
| Upper St. Clair, Pennsylvania, United States, 15241 | |
| Forest Investigative Site 1172 | |
| Warminster, Pennsylvania, United States, 18974 | |
| Forest Investigative Site 1278 | |
| West Chester, Pennsylvania, United States, 19382 | |
| United States, Rhode Island | |
| Forest Investigative Site 1375 | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| Forest Investigative Site 1363 | |
| Charleston, South Carolina, United States, 29412 | |
| Forest Investigative Site 1760 | |
| Charleston, South Carolina, United States, 29407 | |
| Forest Investigative Site 1122 | |
| Columbia, South Carolina, United States, 29204 | |
| Forest Investigative Site 1133 | |
| Greenville, South Carolina, United States, 29615 | |
| Forest Investigative Site 1809 | |
| Greenville, South Carolina, United States, 29615 | |
| Forest Investigative Site 1327 | |
| Greer, South Carolina, United States, 29651 | |
| Forest Investigative Site 1127 | |
| Mt. Pleasant, South Carolina, United States, 29464 | |
| Forest Investigative Site 1310 | |
| Murrells Inlet, South Carolina, United States, 29576 | |
| Forest Investigative Site 1152 | |
| Pelzer, South Carolina, United States, 29669 | |
| Forest Investigative Site 1114 | |
| Simpsonville, South Carolina, United States, 29681 | |
| Forest Investigative Site 1149 | |
| Spartanburg, South Carolina, United States, 29303 | |
| Forest Investigative Site 1113 | |
| Summerville, South Carolina, United States, 29485 | |
| Forest Investigative Site 1806 | |
| Union, South Carolina, United States, 29379 | |
| United States, South Dakota | |
| Forest Investigative Site 1185 | |
| Dakota Dunes, South Dakota, United States, 57049 | |
| Forest Investigative Site 1753 | |
| Rapid City, South Dakota, United States, 57702 | |
| United States, Tennessee | |
| Forest Investigative Site 1402 | |
| Bristol, Tennessee, United States, 37620 | |
| Forest Investigative Site 1037 | |
| Chattanooga, Tennessee, United States, 37421 | |
| Forest Investigative Site 1031 | |
| Clarksville, Tennessee, United States, 37043 | |
| Forest Investigative Site 1074 | |
| Collierville, Tennessee, United States, 38107 | |
| Forest Investigative Site 1033 | |
| Fayetteville, Tennessee, United States, 37334 | |
| Forest Investigative Site 1763 | |
| Kingsport, Tennessee, United States, 37660 | |
| Forest Investigative Site 1744 | |
| Knoxville, Tennessee, United States, 37920 | |
| Forest Investigative Site 1358 | |
| Memphis, Tennessee, United States, 38119 | |
| Forest Investigative Site 1082 | |
| Memphis, Tennessee, United States, 38125 | |
| United States, Texas | |
| Forest Investigative Site 1094 | |
| Arlington, Texas, United States, 76012 | |
| Forest Investigative Site 1311 | |
| Austin, Texas, United States, 78756 | |
| Forest Investigative Site 1245 | |
| Austin, Texas, United States, 78728 | |
| Forest Investigative Site 1174 | |
| Beaumont, Texas, United States, 77701 | |
| Forest Investigative Site 1762 | |
| Boerne, Texas, United States, 78006 | |
| Forest Investigative Site 1244 | |
| Bryan, Texas, United States, 77802 | |
| Forest Investigative Site 1776 | |
| Carrollton, Texas, United States, 75006 | |
| Forest Investigative Site 1205 | |
| Corpus Christi, Texas, United States, 78404 | |
| Forest Investigative Site 1268 | |
| Corsicana, Texas, United States, 75110 | |
| Forest Investigative Site 1213 | |
| Dallas, Texas, United States, 75235 | |
| Forest Investigative Site 1360 | |
| Houston, Texas, United States, 77062 | |
| Forest Investigative Site 1157 | |
| Houston, Texas, United States, 77036 | |
| Forest Investigative Site 1372 | |
| Houston, Texas, United States, 77024 | |
| Forest Investigative Site 1774 | |
| Houston, Texas, United States, 77081 | |
| Forest Investigative Site 1777 | |
| Houston, Texas, United States, 77030 | |
| Forest Investigative Site 1228 | |
| Houston, Texas, United States, 77024 | |
| Forest Investigative Site 1230 | |
| Houston, Texas, United States, 77074 | |
| Forest Investigative Site 1262 | |
| Irving, Texas, United States, 75039 | |
| Forest Investigative Site 1229 | |
| Longview, Texas, United States, 75605 | |
| Forest Investigative Site 1199 | |
| New Braunfels, Texas, United States, 78130 | |
| Forest Investigative Site 1214 | |
| Plano, Texas, United States, 75024 | |
| Forest Investigative Site 1167 | |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site 1295 | |
| San Antonio, Texas, United States, 78218 | |
| Forest Investigative Site 1129 | |
| San Antonio, Texas, United States, 78205 | |
| Forest Investigative Site 1317 | |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site 1766 | |
| San Antonio, Texas, United States, 78209 | |
| Forest Investigative Site 1758 | |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site 1257 | |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site 1186 | |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site 1797 | |
| San Antonio, Texas, United States, 78215 | |
| Forest Investigative Site 1334 | |
| Sugar Land, Texas, United States, 77478 | |
| Forest Investigative Site 1269 | |
| Tomball, Texas, United States, 77375 | |
| Forest Investigative Site 1349 | |
| Waco, Texas, United States, 76710 | |
| United States, Utah | |
| Forest Investigative Site 1015 | |
| Clinton, Utah, United States, 84015 | |
| Forest Investigative Site 1187 | |
| Draper, Utah, United States, 84020 | |
| Forest Investigative Site 1226 | |
| Draper, Utah, United States, 84020 | |
| Forest Investigative Site 1086 | |
| Magna, Utah, United States, 84044 | |
| Forest Investigative Site 1216 | |
| Ogden, Utah, United States, 84405 | |
| Forest Investigative Site 1219 | |
| Orem, Utah, United States, 84058 | |
| Forest Investigative Site 1328 | |
| Riverton, Utah, United States, 84065 | |
| Forest Investigative Site 1771 | |
| Salt Lake City, Utah, United States, 84102 | |
| Forest Investigative Site 1175 | |
| Salt Lake City, Utah, United States, 84107 | |
| Forest Investigative Site 1194 | |
| Salt Lake City, Utah, United States, 84121 | |
| Forest Investigative Site 1197 | |
| Salt Lake City, Utah, United States, 84109 | |
| Forest Investigative Site 1202 | |
| South Jordan, Utah, United States, 84095 | |
| Forest Investigative Site 1773 | |
| St. George, Utah, United States, 84790 | |
| United States, Virginia | |
| Forest Investigative Site 1786 | |
| Arlington, Virginia, United States, 22203 | |
| Forest Investigative Site 1130 | |
| Arlington, Virginia, United States, 22205 | |
| Forest Investigative Site 1020 | |
| Burke, Virginia, United States, 22015 | |
| Forest Investigative Site 1343 | |
| Danville, Virginia, United States, 24541 | |
| Forest Investigative Site 1164 | |
| Manassas, Virginia, United States, 20110 | |
| Forest Investigative Site 1767 | |
| Norfolk, Virginia, United States, 23510 | |
| Forest Investigative Site 1292 | |
| Petersburg, Virginia, United States, 23803 | |
| Forest Investigative Site 1131 | |
| Suffolk, Virginia, United States, 23435 | |
| Forest Investigative Site 1099 | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Forest Investigative Site 1119 | |
| Port Orchard, Washington, United States, 98366 | |
| Forest Investigative Site 1394 | |
| Seattle, Washington, United States, 98104 | |
| Forest Investigative Site 1085 | |
| Spokane, Washington, United States, 99207 | |
| Forest Investigative Site 1335 | |
| Walla Walla, Washington, United States, 99362 | |
| United States, West Virginia | |
| Forest Investigative Site 1377 | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Forest Investigative Site 1367 | |
| Milwaukee, Wisconsin, United States, 53215 | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | David B Bharucha, MD, PhD, FACC | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01508026 History of Changes |
| Other Study ID Numbers: | NAC-MD-01 |
| Study First Received: | January 9, 2012 |
| Last Updated: | May 31, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Forest Laboratories:
|
Stage 1 Stage 2 Hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Nebivolol Valsartan 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 Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013