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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR BYSTOLIC

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All Clinical Trials for Bystolic

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00223717 ↗ Treatment of Supine Hypertension in Autonomic Failure Recruiting Vanderbilt University Medical Center Phase 1/Phase 2 2001-06-01 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 2008-05-01 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 2009-01-01 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 2009-01-01 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 2009-05-01 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.
NCT00893984 ↗ Alternative in Beta Blocker Intolerance: The ABBI Trial Terminated Minneapolis Heart Institute Foundation Phase 4 2009-05-01 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.
NCT00992056 ↗ Nebivolol Versus Metoprolol: Sodium Sensitivity Completed Forest Laboratories Phase 4 2010-12-01 Research objectives The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is to determine the effects of nebivolol versus metoprolol on ambulatory blood pressure, the blood pressure response to dietary sodium loading, and renal handling of an acute sodium load in postmenopausal women with hypertension. Hypothesis Nebivolol will result in a blunted response of blood pressure to oral sodium administration and improved renal handling of an intravenous sodium load in comparison with metoprolol in hypertensive postmenopausal women. Research plan Study design The study consisted of a randomized crossover trial of the effects on sodium sensitivity and renal sodium handling of nebivolol versus metoprolol. All study procedures were carried out under the direct supervision of the Principal Investigator in the outpatient and inpatient research unit of the University of Miami Division of Clinical Pharmacology. Primary endpoint Change in 24-hour mean systolic blood pressure determined by 24-hour ambulatory blood pressure monitor (ABPM) from the final day of low sodium to the final day of high sodium in nebivolol versus metoprolol
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bystolic

Condition Name

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

Condition MeSH for Bystolic
Intervention Trials
Hypertension 17
Prehypertension 3
Pure Autonomic Failure 2
Myocardial Ischemia 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 Texas Southwestern Medical Center 2
Torrent Pharmaceuticals Limited 2
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Sponsor Type

Sponsor Type for Bystolic
Sponsor Trials
Other 27
Industry 26
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