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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Criteria

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.