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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR TEKTURNA

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Clinical Trials for Tekturna

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.
NCT00627861 Combined Renin Inhibition/Beta-blockade Terminated The Rogosin Institute N/A Antihypertensive drug treatment is effective in only about 50% of patients. One mechanism responsible for treatment failure is a drug related stimulation of the renin-angiotension-aldosterone-system (RAAS). Several classes of medications that treat hypertension by blocking the RAAS system have been developed. However, the kidney responds to these drug treatments by producing greater amounts of renin. This high level of renin can reduce the effectiveness of some of these medications, ultimately causing the blood pressure to rise. This is one reason why blood pressure can be difficult to control in a certain percentage of patients. The hypothesis to be tested in the proposed study is that beta-adrenergic blockade (β-blockade), when superimposed upon aliskiren, a drug that competitively inhibits plasma renin activity (PRA) but stimulates the release of renin by the kidneys (plasma renin concentration [PRC]), can suppress the reactive increase in PRC that occurs during aliskiren monotherapy. The primary aim of this study is to measure plasma renin concentration (PRC) and plasma renin activity (PRA) levels during renin inhibition with aliskiren and combined renin inhibition/β-blocker treatment to determine whether the addition of a β-blocker attenuates the rise in plasma renin concentration (PRC). A secondary aim is to determine whether combined treatment further suppresses PRA and blood pressure.
NCT00773084 Aliskiren and Renin Inhibition in Diastolic Heart Failure Withdrawn Texas Tech University Health Sciences Center N/A This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.
NCT00818779 Direct Renin Inhibition Effects on Atherosclerotic Biomarkers Completed Texas Tech University Health Sciences Center Phase 4 The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calcium channel blocker.
NCT00961207 Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients Terminated John H. Stroger Hospital Phase 4 Study Hypothesis: Reduction in albuminuria has been shown to decrease progression of diabetic nephropathy. In diabetic nephropathy patients treated with maximal antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320 mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent albuminuria reflects further additional RAAS activation. Microvascular renal disease due to increased RAAS activation may be more effectively treated with triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.
NCT00974922 Vitamin D Deficiency in Patients With Hypertension Terminated Novartis Phase 4 This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
NCT00974922 Vitamin D Deficiency in Patients With Hypertension Terminated UConn Health Phase 4 This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Tekturna

Condition Name

Condition Name for Tekturna
Intervention Trials
Hypertension 6
Diabetes 2
Proteinuria 1
Focal Segmental Glomerulosclerosis 1
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Condition MeSH

Condition MeSH for Tekturna
Intervention Trials
Hypertension 5
Kidney Diseases 3
Heart Failure 2
Glomerulonephritis, Membranous 2
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Clinical Trial Locations for Tekturna

Trials by Country

Trials by Country for Tekturna
Location Trials
United States 17
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Trials by US State

Trials by US State for Tekturna
Location Trials
Massachusetts 2
Minnesota 2
Michigan 2
Texas 2
New York 2
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Clinical Trial Progress for Tekturna

Clinical Trial Phase

Clinical Trial Phase for Tekturna
Clinical Trial Phase Trials
Phase 4 10
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Tekturna
Clinical Trial Phase Trials
Terminated 9
Completed 3
Unknown status 2
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Clinical Trial Sponsors for Tekturna

Sponsor Name

Sponsor Name for Tekturna
Sponsor Trials
Novartis 7
Novartis Pharmaceuticals 3
Texas Tech University Health Sciences Center 2
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Sponsor Type

Sponsor Type for Tekturna
Sponsor Trials
Other 17
Industry 11
NIH 2
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Moodys
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