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

Overview

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

Full Title of Study: “A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2009

Interventions

  • Drug: Olmesartan medoxomil
    • 40mg olmesartan medoxomil
  • Drug: Amlodipine
    • Amlodipine 10mg
  • Drug: Hydrochlorothiazide
    • Hydrochlorothiazide 25mg

Arms, Groups and Cohorts

  • Experimental: OM40/AML10
    • olmesartan medoxomil 40mg and amlodipine 10mg
  • Active Comparator: OM40/HCTZ25
    • olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
  • Active Comparator: AML10/HCTZ25
    • amlodipine 10mg and hydrochlorothiazide 25mg
  • Active Comparator: OM40/AML10/HCTZ25
    • olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
    • Time Frame: baseline to 12 weeks

Secondary Measures

  • Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks
    • Time Frame: Baseline to 12 weeks
  • Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination
    • Time Frame: Baseline to 12 weeks or early termination
  • Change in Seated Systolic Blood Pressure From Baseline to Week 12
    • Time Frame: Baseline to week 12

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo
  • Provider of Information About this Clinical Study
    • Executive Director Clinical Development, Daiichi Sankyo Inc.

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