A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension

INTERVENTION: Product Name: Carvedilol Egalet® Formulation Pharmaceutical Form: Capsule* INN or Proposed INN: Carvedilol CAS Number: 72956‐09‐03 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ INN or Proposed INN: Carvedilol CAS Number: 72956‐09‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Pharmaceutical Form: Capsule* INN or Proposed INN: Carvedilol CAS Number: 72956‐09‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Carvedilol Egalet® Formulation Pharmaceutical Form: Capsule* INN or Proposed INN: Carvedilol CAS Number: 72956‐09‐03 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ INN or Proposed INN: Carvedilol CAS Number: 72956‐09‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ CONDITION: Hypertension ; MedDRA version: 8.1 Level: LLT Classification code 10020772 Term: Hypertension PRIMARY OUTCOME: Main Objective: The primary objective of this trial is to evaluate the efficacy of Egalet formulation of Controlled‐Release Carvedilol (CRC) compared to Immediate‐Release Carvedilol (IRC) after 3 weeks of treatment. Primary end point(s): The primary efficacy endpoint for this study is:; •The change from baseline to 3 weeks treatment in systolic blood pressure (SBP) at the end of five minutes of sub‐maximal exercise for the Egalet formulation of Controlled‐Release Carvedilol (CRC) compared to Immediate‐Release Carvedilol (IRC).; Secondary Objective: The secondary objective of this trial is to evaluate the safety and tolerability of CRC and IRC after 3 weeks of treatment. INCLUSION CRITERIA: To be eligible for enrollment into this study, a patient MUST: •Provide written informed consent. •Be > 18 years of age. •Be currently using an approved form of birth control if a female of child‐bearing potential. •Have a diagnosis of mild or moderate primary hypertension with (1) seated SBP > 140 and < 179 mmHg, AND (2) seated diastolic blood pressure (DBP) > 90 and < 114 mmHg. Patients with either a seated SBP or a seated DBP outside of these specified ranges will not be included. •Be able to tolerate a 2‐week Washout Phase followed by a 2‐week Placebo Run‐In Phase with no antihypertensive medication treatment. •Be willing and able to maintain current dietary and exercise regimens throughout the study. •Be willing and able to comply with all protocol requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range