Treatment Trials

25 Clinical Trials for Various Conditions

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COMPLETED
Taekwondo Training and Postmenopausal Women With Stage-2 Hypertension
Description

Aging is associated with hormonal imbalances and progressive decreases in arterial health and function. It is crucial to prevent or reduce the negative effects of aging on hormonal balance and the vasculature by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a 12-week Taekwondo training program on blood catecholamines, arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), resting heart rate, and muscular strength in postmenopausal women with stage 2 hypertension.

COMPLETED
Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
Description

The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.

Conditions
TERMINATED
Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
Description

This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

COMPLETED
Nebivolol in Patients With Systolic Stage 2 Hypertension
Description

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Conditions
COMPLETED
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
Description

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.

Conditions
COMPLETED
8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 Hypertension
Description

To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.

COMPLETED
Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Description

Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension

Conditions
COMPLETED
Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans
Description

The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.

Conditions
COMPLETED
Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension
Description

The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg \[Micardis HCT\] to valsartan 160 mg / hydrochlorothiazide 25 mg \[Diovan HCT\] and placebo in the treatment of Stage 1 and Stage 2 hypertension.

Conditions
ACTIVE_NOT_RECRUITING
REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /
Description

This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.

COMPLETED
Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension
Description

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

COMPLETED
Rheos® Pivotal Trial
Description

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a diuretic.

Conditions
COMPLETED
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
Description

This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).

COMPLETED
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Description

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

COMPLETED
Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension
Description

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).

Conditions
COMPLETED
Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus
Description

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).

COMPLETED
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population
Description

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

Conditions
COMPLETED
Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine
Description

Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.

COMPLETED
Phase 1, Randomized, Double-Blind, Placebo-Controlled Exploratory Study That Will Assess the Safety, Tolerability, Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera™ (PB1046) in Adult Subjects With Stage 1 or 2 Essential Hypertension
Description

This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.

COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension
Description

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage 1 or Stage 2 essential hypertension. The secondary objectives of the study are to characterize the pharmacokinetic profile of single ascending doses of Vasomera and the relationship between serum concentrations of Vasomera and change in systolic and diastolic blood pressure as measured by: * Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) as compared to placebo. * Identification of the minimum and maximum decrease in systolic and diastolic blood pressure as measured by ABPM. * Mean change from baseline in cuff systolic and diastolic blood pressure as compared to placebo. * Effect of Vasomera on pulse pressure and heart rate. An additional secondary objective of this study will be to characterize the immunogenicity profile of Vasomera following a single subcutaneous dose.

COMPLETED
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure
Description

Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (\<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (\<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.

Conditions
COMPLETED
Preserving Kidney Function in Children With Chronic Kidney Disease
Description

Pediatric chronic kidney disease (CKD) results from health conditions that reduce kidney function for \>3 months. It can progress to end-stage kidney disease (ESKD), which requires dialysis or kidney transplant. In adults, CKD is common and caused mainly by hypertension and diabetes. CKD in childhood is rare and caused primarily by congenital anomalies of the genitourinary system and immune-mediated disorders. The best estimate of pediatric CKD prevalence is \<1/15,000 pediatric population. Hypertension occurs in 50% of affected children and is a major risk factor for decline in kidney function. Several clinical practice guidelines have offered recommendations for blood pressure (BP) management in pediatric CKD; however, clinical trial and large-scale observational data are limited, leading to a weak evidence base and substantial practice variation. The purpose of PRESERVE is to provide new knowledge to inform shared decision-making regarding BP management for pediatric CKD. We will leverage the Patient-Centered Outcomes Research network (PCORnet®) infrastructure to conduct large-scale observational studies that will address BP management knowledge gaps for pediatric CKD and sub-groups for whom antihypertensive treatment and outcome associations may be different (e.g., cause of kidney disease and proteinuria). The project's specific aims are: Aim 1-Enhance the PCORnet Common Data Model (CDM) for pediatric and rare kidney disease research. We will expand and improve the PCORnet CDM with new pediatric- and kidney-specific variables, study-specific data quality optimization, and linkage with the chronic kidney disease in children (CKiD) cohort study and the US Renal Data System (USRDS). CKiD directly measures kidney function \[ie, glomerular filtration rate (GFR)\] and includes Ambulatory Blood Pressure Monitoring (ABPM). The USRDS provides complete capture of renal replacement therapy \[(RRT) dialysis and transplant\], two components of the primary clinical outcome. Aim 2-Describe and examine the effectiveness of consistent BP and urine protein monitoring for preserving kidney function. We will describe the consistency of BP and urine protein monitoring and will contrast clinic BP assessments with ABPM. In longitudinal analyses, we will evaluate the effects of consistent monitoring of BP and urine protein on kidney function decline. Aim 3-Compare the effectiveness of BP medication strategies for preserving kidney function. We will compare the effects of (1) BP levels when treatment was started, (2) choice of first-line therapies, and (3) ongoing BP control on kidney function decline. We will also assess adverse events related to hypertension management. Aim 4-Assess patients' lived experiences related to BP management. We will field a survey that examines patient-centered outcomes by level of BP control and medication management approaches. This Aim will provide information on experiences with BP management from the perspectives of patients, parents, and clinicians that will complement the clinical outcomes studied in Aims 2 and 3.

COMPLETED
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Description

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Conditions
ACTIVE_NOT_RECRUITING
Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
Description

For this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: Subjects will get randomized into either Group A: Large Volume Paracentesis (LVP) with albumin infusion, or Group B: an early transjugular intrahepatic portosystemic shunt (TIPS) procedure.

COMPLETED
Center of Research Translation (CORT) Project 2
Description

We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole.