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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Olmesartan medoxomil (Drug); Amlodipine (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).

Secondary outcome:

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

Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination

Change in Seated Systolic Blood Pressure From Baseline to Week 12

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

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Additional Information

Starting date: May 2008
Last updated: August 31, 2010

Page last updated: August 20, 2015

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