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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR METOPROLOL TARTRATE

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Clinical Trials for Metoprolol Tartrate

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.
NCT00648271 Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg tablets for Mylan's formulation and 1 x 50 mg for Lopressor®) dose administered under fed conditions.
NCT00649116 Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis's Lopressor® tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
NCT00649233 Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fed conditions.
NCT00649688 Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fasting conditions.
NCT00806390 Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol Terminated University of Maryland Phase 4 The primary objective of this study is to investigate whether giving prophylactic metoprolol prior to and during anthracycline or trastuzumab therapy will decrease the incidence of anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured by nuclear ventriculography is measured before and after treatment.
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting Conselho Nacional de Desenvolvimento Científico e Tecnológico Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Metoprolol Tartrate

Condition Name

Condition Name for Metoprolol Tartrate
Intervention Trials
Healthy 6
Hypertension 3
Heart Diseases 1
Peripheral Artery Disease 1
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Condition MeSH

Condition MeSH for Metoprolol Tartrate
Intervention Trials
Hypertension 2
Pure Autonomic Failure 1
Atrial Fibrillation 1
Peripheral Arterial Disease 1
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Clinical Trial Locations for Metoprolol Tartrate

Trials by Country

Trials by Country for Metoprolol Tartrate
Location Trials
United States 10
Denmark 1
Korea, Republic of 1
Australia 1
China 1
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Trials by US State

Trials by US State for Metoprolol Tartrate
Location Trials
North Dakota 2
West Virginia 2
Tennessee 2
Arizona 1
Missouri 1
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Clinical Trial Progress for Metoprolol Tartrate

Clinical Trial Phase

Clinical Trial Phase for Metoprolol Tartrate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Metoprolol Tartrate
Clinical Trial Phase Trials
Completed 7
Recruiting 4
Enrolling by invitation 1
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Clinical Trial Sponsors for Metoprolol Tartrate

Sponsor Name

Sponsor Name for Metoprolol Tartrate
Sponsor Trials
Mylan Pharmaceuticals 4
National Heart, Lung, and Blood Institute (NHLBI) 1
The Stroke Association, United Kingdom 1
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Sponsor Type

Sponsor Type for Metoprolol Tartrate
Sponsor Trials
Other 13
Industry 7
NIH 1
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