Back to resultsOlmesartan Medoxomil in Hypertension and Renal Impairment
Primary Purpose
Essential Hypertension, Renal Impairment
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Olmesartan medoxomil
Losartan
Furosemide oral tablets
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Olmesartan medoxomil
Losartan
Arm Description
Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
Outcomes
Primary Outcome Measures
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
Secondary Outcome Measures
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;
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;
Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg
Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
Changes in serum creatinine after 12 and 52 weeks of treatment
Rate of patients per dose level after 12 and 52 weeks of treatment
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00151827
Brief Title
Olmesartan Medoxomil in Hypertension and Renal Impairment
Official Title
Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sankyo Pharma Gmbh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
393 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olmesartan medoxomil
Arm Type
Experimental
Arm Description
Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
Arm Title
Losartan
Arm Type
Experimental
Arm Description
Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Description
Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Medications are taken once daily before breakfast with water.
Intervention Type
Drug
Intervention Name(s)
Furosemide oral tablets
Intervention Description
If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Description
Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg
Time Frame
Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks
Title
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
Title
Changes in serum creatinine after 12 and 52 weeks of treatment
Time Frame
Baseline to 12 and 52 weeks
Title
Rate of patients per dose level after 12 and 52 weeks of treatment
Time Frame
Baseline to 12 and 52 weeks
Title
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment
Time Frame
Baseline to 4, 12, 24, 36 and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. U. Witte, MD, PhD
Organizational Affiliation
IMFORM GmbH, Darmstadt, Germany
Official's Role
Principal Investigator
Facility Information:
City
Darmstadt
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Olmesartan Medoxomil in Hypertension and Renal Impairment
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