Clinical trial NCT00151827: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Renal Impairment
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: 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;
timeFrame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
measure: 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;
timeFrame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
measure: Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
timeFrame: Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks
measure: Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
timeFrame: Baseline to 12 and 52 weeks
measure: Changes in serum creatinine after 12 and 52 weeks of treatment
timeFrame: Baseline to 12 and 52 weeks
measure: Rate of patients per dose level after 12 and 52 weeks of treatment
timeFrame: Baseline to 12 and 52 weeks
measure: Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment
timeFrame: Baseline to 4, 12, 24, 36 and 52 weeks
Other outcomes:
Locations:
city: Darmstadt
country: Germany
Study officials:
affiliation: IMFORM GmbH, Darmstadt, Germany
name: P. U. Witte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: