Olmesartan Medoxomil in Hypertension and Renal Impairment - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

October 11, 2007

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00151827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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.

Original Secondary Outcome Measures ^ICMJE

- Change in mean sitting dBP, assessed by conventional BP
measurements
- Change in mean sitting sBP, assessed by conventional BP
- Response to treatment (i.e. mean sitting dBP less than
or equal to 90 mmHg or reduction greater than or equal to
10 mmHg)
- Changes in CLcr and serum creatinine after 12 and 52
weeks of treatment, changes in proteinuria
- Onset of BP lowering effect
- Safety and tolerability

Descriptive Information

Brief Title ^ICMJE

Olmesartan Medoxomil in Hypertension and Renal Impairment

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Essential Hypertension
Renal Impairment

Intervention ^ICMJE

Drug: Olmesartan medoxomil
Drug: Losartan
Drug: Furosemide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00151827

Responsible Party

Study ID Numbers ^ICMJE

SE-866/43

Study Sponsor ^ICMJE

Sankyo Pharma Gmbh

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

P. U. Witte, MD, PhD

IMFORM GmbH, Darmstadt, Germany

Information Provided By

Daiichi Sankyo Inc.

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP