Olmesartan Medoxomil in Hypertension and Renal Impairment - Full Text View

Sponsored by:	Sankyo Pharma Gmbh
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00151827

Purpose

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

Condition	Intervention	Phase
Essential Hypertension Renal Impairment	Drug: Olmesartan medoxomil Drug: Losartan Drug: Furosemide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Furosemide Losartan Losartan potassium Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

- 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.

Estimated Enrollment:	400
Study Start Date:	August 2003
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151827

Locations

Germany

Darmstadt, Germany

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:

P. U. Witte, MD, PhD

IMFORM GmbH, Darmstadt, Germany

More Information

No publications provided

Study ID Numbers:	SE-866/43
Study First Received:	September 8, 2005
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00151827 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Essential Hypertension
Losartan
Diuretics
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Angiotensin II
Furosemide
Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Sodium Potassium Chloride Symporter Inhibitors
Hypertension

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents
Furosemide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Sodium Potassium Chloride Symporter Inhibitors
Hypertension

ClinicalTrials.gov processed this record on August 30, 2009