Olmesartan Medoxomil in Hypertension and Renal Impairment

Condition(s) targeted: Essential Hypertension; Renal Impairment

Intervention: Olmesartan medoxomil (Drug); Losartan (Drug); Furosemide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sankyo Pharma Gmbh

Official(s) and/or principal investigator(s):
P. U. Witte, MD, PhD, Principal Investigator, Affiliation: IMFORM GmbH, Darmstadt, Germany

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in mean sitting diastolic blood pressure (dBP), assessed by conventional BP measurements after 12 weeks of treatment

Secondary outcome:

- Change in mean sitting dBP, assessed by conventional BP measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;

- Change in mean sitting sBP, assessed by conventional BP measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;

- Response to treatment (i.e. mean sitting dBP less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg) after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;

- Changes in CLcr and serum creatinine after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;

- Onset of BP lowering effect;

- Rate of patients per dose level after 12 and 52 weeks of treatment;

- Safety and tolerability.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Darmstadt, Germany

Starting date: August 2003
Ending date: February 2006
Last updated: October 11, 2007