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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR BYSTOLIC

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Clinical Trials for Bystolic

Trial ID Title Status Sponsor Phase Summary
NCT00223717 Treatment of Supine Hypertension in Autonomic Failure Recruiting Vanderbilt University Medical Center Phase 1/Phase 2 Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00673075 The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease Completed Forest Laboratories Phase 4 This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.
NCT00829296 Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries Completed Forest Laboratories Phase 2/Phase 3 The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
NCT00829296 Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries Completed University of Chicago Phase 2/Phase 3 The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
NCT00893984 Alternative in Beta Blocker Intolerance: The ABBI Trial Terminated Forest Laboratories Phase 4 In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use. The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Bystolic

Condition Name

Condition Name for Bystolic
Intervention Trials
Hypertension 22
Coronary Artery Disease 2
Prehypertension 2
Healthy Subjects 2
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Condition MeSH

Condition MeSH for Bystolic
Intervention Trials
Hypertension 17
Prehypertension 3
Coronary Artery Disease 2
Pure Autonomic Failure 2
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Clinical Trial Locations for Bystolic

Trials by Country

Trials by Country for Bystolic
Location Trials
United States 61
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Trials by US State

Trials by US State for Bystolic
Location Trials
Florida 5
California 4
Tennessee 4
Georgia 4
Texas 4
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Clinical Trial Progress for Bystolic

Clinical Trial Phase

Clinical Trial Phase for Bystolic
Clinical Trial Phase Trials
Phase 4 19
Phase 3 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Bystolic
Clinical Trial Phase Trials
Completed 19
Terminated 4
Unknown status 3
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Clinical Trial Sponsors for Bystolic

Sponsor Name

Sponsor Name for Bystolic
Sponsor Trials
Forest Laboratories 23
University of Colorado, Boulder 2
University of Chicago 2
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Sponsor Type

Sponsor Type for Bystolic
Sponsor Trials
Other 27
Industry 26
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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Medtronic
Queensland Health
McKinsey
Harvard Business School
QuintilesIMS
Julphar
Teva
Chinese Patent Office

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