Olmesartan Medoxomil in Hypertension and Renal Impairment - Tabular View

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Olmesartan Medoxomil in Hypertension and Renal Impairment

This study has been completed.
Information provided by Daiichi Sankyo Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

- 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.

Condition ^†

Essential Hypertension
Renal Impairment

Intervention ^†

Drug: Olmesartan medoxomil
Drug: Losartan
Drug: Furosemide

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

400

Start Date ^†

August 2003

Completion Date

February 2006

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Administrative Information Fields

NCT ID ^†

NCT00151827

Organization ID

SE-866/43

Secondary IDs ^††

Study Sponsor ^†

Sankyo Pharma Gmbh

Collaborators ^††

Investigators ^†

Principal Investigator:

P. U. Witte, MD, PhD

IMFORM GmbH, Darmstadt, Germany

Information Provided By

Daiichi Sankyo Inc.

Verification Date

October 2007

First Received Date ^†

September 8, 2005

Last Updated Date

October 11, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.