Status:
COMPLETED
Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pres...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00649389
Start Date
May 1 2008
End Date
December 1 2009
Last Update
January 9 2019
Active Locations (232)
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
3
Gulf Shores, Alabama, United States
4
Hoover, Alabama, United States