Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

Inclusion Criteria:

- Demonstrable hypertension defined as mean sitting trough cuff blood pressure ≥ 140/100
mmHg (SeSBP ≥ 140 mmHg and SeDBP ≥ 100mmHg) or mean sitting trough cuff BP ≥ 160/90
mmHg (SeSBP ≥ 160 mmHg and SeDBP ≥ 90mmHg).

- Male or female newly diagnosed hypertensive subjects or currently on hypertension
medication.

- Negative urine pregnancy test at screening

- Not lactating

- Do not plan to become pregnant during the study

- Will practice birth control throughout the study by the following: oral or patch
contraceptive, injectable or implantable contraceptive medication, intrauterine
device, diaphragm or female condom plus spermicide

- Non childbearing potential must be classified by one of the following
criteria

- Had a hysterectomy or tubal ligation at least 6 months prior to consent

- Has been postmenopausal for a least 1 year

Exclusion Criteria:

- Mean sitting trough cuff DBP <90 mmHg or mean sitting trough cuff SBP <140 mmHg (off
antihypertensive medication).

- Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at
the discretion of the investigator).

- Signs or symptoms which could exacerbate the occurrence of hypotension such as volume
and salt depletion.

- History of hypertensive encephalopathy, stroke or transient ischemic attack (TIA).

- Participation in another clinical trial involving an investigational drug within one
month prior to screening.

- History of myocardial infarction, percutaneous transluminal coronary
revascularization, coronary artery bypass graft, and/or unstable angina within the
past 6 months.

- Any history of New York Heart Association Class III or IV congestive heart failure
(CHF). A history of New York Heart Association Class I or II CHF may be exclusionary
at the discretion of the investigator.

- History of secondary hypertension including renal disease, pheochromocytoma, or
Cushing's syndrome.

- Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral
renal artery stenosis in a solitary kidney.

- Evidence of symptomatic resting bradycardia.

- Evidence of hemodynamically significant cardiac valvular disease.

- Presence of heart block greater than first degree atrioventricular block, chronic
atrial fibrillation or flutter.

- Uncontrolled Type I or Type II diabetes defined as HbA1c >9.0%. Diabetics must have
documentation of HbA1c within 6 months of the Screening Visit. Undocumented subjects
must have their HbA1c assessed prior to randomization. Note: Subjects with Type I or
Type II diabetes controlled with insulin, diet or oral hypoglycemic agents on a stable
dose for at least 30 days may be included.

- Evidence of liver disease as indicated by ALT and AST and/or total bilirubin >3 times
the upper limit of normal.

- Severe renal insufficiency defined as a creatinine clearance (based on the
Cockcroft-Gault formula) of <30 mL/min.

- Clinically significant laboratory elevations at Visit 1 that compromise subject
safety, based on the investigator's judgment. Consideration should take into account
the potential laboratory effects of the component blinded therapies.

- Positive for any one of the following tests: hepatitis B surface antigen, hepatitis C
antibody (confirmed by radio immunobinding assay, RIBA) or HIV antibody (confirmed by
western blot assay).

- Subjects with malignancy during the past 2 years excluding squamous cell or basal cell
carcinoma of the skin.

- Known allergy to any of the medications used in the study.

- Subjects who require or are taking any concomitant medication, which may interfere
with the objectives of the study (Refer to Section 5.2 for a listing of excluded
medications).

- Pregnant or lactating females.

- Current history of drug or alcohol abuse.

- A subject with any medical condition, which in the judgment of the Investigator would
jeopardize the evaluation of efficacy or safety and/or constitute a significant safety
risk to the subject.