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Olmesartan Medoxomil in Hypertension and Renal Impairment

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ClinicalTrials.gov Identifier: NCT00151827
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : October 14, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.

Condition or disease Intervention/treatment Phase
Essential Hypertension Renal Impairment Drug: Olmesartan medoxomil Drug: Losartan Drug: Furosemide oral tablets Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
Study Start Date : August 2003
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Olmesartan medoxomil
Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
 Drug: Olmesartan medoxomil
Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Drug: Furosemide oral tablets
If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
Experimental: Losartan
Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
 Drug: Losartan
Medications are taken once daily before breakfast with water.

Drug: Furosemide oral tablets
If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :
  1. Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment; [ Time Frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks ]
  2. Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment; [ Time Frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks ]
  3. Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment; [ Time Frame: Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks ]
    Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg

  4. Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment; [ Time Frame: Baseline to 12 and 52 weeks ]
  5. Changes in serum creatinine after 12 and 52 weeks of treatment [ Time Frame: Baseline to 12 and 52 weeks ]
  6. Rate of patients per dose level after 12 and 52 weeks of treatment [ Time Frame: Baseline to 12 and 52 weeks ]
  7. Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment [ Time Frame: Baseline to 4, 12, 24, 36 and 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
  • Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity

Exclusion Criteria:

  • Malignant hypertension or sitting BP greater than 180/109 mmHg;
  • Severe heart failure, severe renal disease;
  • Recent history of myocardial infarction, stroke or transient ischemic attack;
  • History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
  • Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
  • Treatment with dis-allowed medication;
  • Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
  • History of drug and/or alcohol abuse
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151827


Locations
Germany
Darmstadt, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
Principal Investigator: P. U. Witte, MD, PhD IMFORM GmbH, Darmstadt, Germany
More Information
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ClinicalTrials.gov Identifier: NCT00151827     History of Changes
Other Study ID Numbers: SE-866/43
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: October 14, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Hypertension
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Losartan
Olmesartan
Olmesartan Medoxomil
Furosemide
 Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators