Essential Hypertension, Renal Impairment
Conditions
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.
Interventions
DRUGOlmesartan medoxomil
Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
DRUGLosartan
Medications are taken once daily before breakfast with water.
DRUGFurosemide 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
Sponsors
Sankyo Pharma Gmbh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment | Baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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; | Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks | — |
| 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; | Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks | — |
| Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment; | 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 |
| Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment; | Baseline to 12 and 52 weeks | — |
| Changes in serum creatinine after 12 and 52 weeks of treatment | Baseline to 12 and 52 weeks | — |
| Rate of patients per dose level after 12 and 52 weeks of treatment | Baseline to 12 and 52 weeks | — |
| Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment | Baseline to 4, 12, 24, 36 and 52 weeks | — |
Countries
Germany
Outcome results
None listed