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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR INSPRA

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Clinical Trials for Inspra

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.
NCT00293150 PREDICT: Eplerenone in Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure Completed The Cleveland Clinic Phase 4 The principle aim is to determine the efficacy of eplerenone in patients with diastolic heart failure to reverse cardiac remodeling and to improve diastolic function.
NCT00825188 A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives Completed University of Mississippi Medical Center N/A Obesity and hypertension are independent risks for congestive heart failure (CHF) and chronic kidney disease. In obesity induced hypertension, the most common cause of human essential hypertension, the potential importance of mineralocorticoid receptor blockade has not been widely investigated. We propose to test the hypothesis that eplerenone reduces metabolic demand, improves cardiac function and attenuates glomerular hyperfiltration and microalbuminuria in obese patients. Our specific aims are to assess changes in basal metabolic rate, cardiac and renal function in obese hypertensive subjects treated with eplerenone compared to amlodipine.
NCT00865176 Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions Completed Sandoz Phase 1 The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.
NCT00865618 Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions Completed Sandoz Phase 1 The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.
NCT01146197 Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics Completed Assistance Publique - Hôpitaux de Paris Phase 1/Phase 2 Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.
NCT01473108 Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862 Completed Bayer Phase 1 Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Inspra

Condition Name

Condition Name for Inspra
Intervention Trials
Hypertension 4
Gitelman Syndrome 1
Diastolic Heart Failure 1
Sciatic Radiculopathy 1
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Condition MeSH

Condition MeSH for Inspra
Intervention Trials
Hypertension 2
Central Serous Chorioretinopathy 2
Back Pain 1
Syndrome 1
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Clinical Trial Locations for Inspra

Trials by Country

Trials by Country for Inspra
Location Trials
United States 6
Netherlands 1
Germany 1
France 1
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Trials by US State

Trials by US State for Inspra
Location Trials
Ohio 2
New Jersey 1
Mississippi 1
Tennessee 1
Pennsylvania 1
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Clinical Trial Progress for Inspra

Clinical Trial Phase

Clinical Trial Phase for Inspra
Clinical Trial Phase Trials
Phase 4 3
Phase 1/Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Inspra
Clinical Trial Phase Trials
Completed 6
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for Inspra

Sponsor Name

Sponsor Name for Inspra
Sponsor Trials
Sandoz 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 1
Vanderbilt University Medical Center 1
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Sponsor Type

Sponsor Type for Inspra
Sponsor Trials
Other 9
Industry 3
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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
US Department of Justice
Julphar
Johnson and Johnson
Baxter
Federal Trade Commission
Moodys
Cipla

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