Treatment Trials

11 Clinical Trials for Various Conditions

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WITHDRAWN
Mechanism of Masked Hypertension - Intervention
Description

To test the hypothesis that sympatholytic antihypertensive antihypertensive therapy (αβ-blocker - carvedilol) will reduce out-of-clinic ambulatory BP to a greater extent by blocking sympathetic activity than non-sympatholytic antihypertensive medication (dihydropyridine calcium channel blocker - amlodipine) in individuals with masked hypertension.

COMPLETED
Treatment of Masked Hypertension
Description

To date, most observational and all intervention studies have defined hypertension on the basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP (masked hypertension). We demonstrated that, among participants from the Chronic Renal Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and elevated proteinuria are associated with increased odds of masked hypertension. Additionally, participants with masked hypertension had increased risk for target organ damage as assessed by left ventricular mass and pulse wave velocity. These results in participants with CKD are consistent with prior studies in patients with normal renal function that demonstrated a two-fold increased risk for cardiovascular events in patients with masked hypertension compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for adverse outcomes, patients with masked hypertension have been excluded from hypertension trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in target organ damage and adverse cardiovascular outcomes associated with treatment of hypertension extends to patients with masked hypertension. To address this important gap in knowledge, we are planning a randomized, controlled trial to evaluate whether antihypertensive treatment can modify BP patterns in patients with masked hypertension, that is, convert them to controlled clinic and ambulatory BP. We will also evaluate the effect antihypertensive treatment on target organ damage in patients with masked hypertension. The current study is a pilot randomized controlled trial to evaluate the feasibility of the planned trial and the effect of antihypertensive therapy on clinic and ambulatory BP, proteinuria, and target organ damage in patients with masked hypertension.

UNKNOWN
Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
Description

Prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution, 0.005% (TC-002) compared to latanoprost Ophthalmic Solution, 0.005% (LAT) in subjects with elevated intraocular pressure at approximately 20 study sites located in the United States

COMPLETED
Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Description

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

COMPLETED
Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Description

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

COMPLETED
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Description

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

COMPLETED
Double-masked Study of AR-13324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Description

To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5%

COMPLETED
A Phase 2 Single-Masked, Randomized Study of Latanoprost PPDS in Ocular Hypertension or Open-Angle Glaucoma
Description

Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS placement on efficacy will also be examined.

COMPLETED
Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-weeks, Masked Evaluator, Phase IV Multi-center Study in the US
Description

Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost

COMPLETED
A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
Description

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

COMPLETED
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
Description

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.