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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00649389
First received: March 28, 2008
Last updated: August 31, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Olmesartan medoxomil
Drug: Amlodipine
Drug: Hydrochlorothiazide
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in Seated Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

Enrollment: 2500
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OM40/AML10
olmesartan medoxomil 40mg and amlodipine 10mg
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc
Active Comparator: OM40/HCTZ25
olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg
Active Comparator: AML10/HCTZ25
amlodipine 10mg and hydrochlorothiazide 25mg
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg
Active Comparator: OM40/AML10/HCTZ25
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00649389

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Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Director Clinical Development, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00649389     History of Changes
Other Study ID Numbers: CS8635-A-U301
Study First Received: March 28, 2008
Results First Received: August 9, 2010
Last Updated: August 31, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Olmesartan
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 22, 2014