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Completed

NCT Number: NCT00151827

Olmesartan Medoxomil in Hypertension and Renal Impairment

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

Losartan

Drug

Medications are taken once daily before breakfast with water.

Furosemide oral tablets

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sankyo Pharma Gmbh

Industry

Registry information

Official study title

Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 9, 2005
Registry last updated
Oct 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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