Isolated Systolic Hypertension in the Elderly and Very Elderly - Full Text View

Sponsored by:	Daiichi Sankyo Europe, GmbH
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00751829

Purpose

To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.

Condition	Intervention	Phase
Isolated Systolic Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary Drug: nitrendipine + hydrochlorothiazide, if necessary	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Nitrendipine Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change in mean sitting systolic blood pressure as assessed by conventional BP measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean sitting systolic blood pressure assessed by conventional BP measurements [ Time Frame: After 1, 2, 4, 8, 12, 16, 20, and 24 weeks ] [ Designated as safety issue: No ]
Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP [ Time Frame: after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	417
Study Start Date:	July 2003
Study Completion Date:	February 2005
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
2: Active Comparator oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP	Drug: nitrendipine + hydrochlorothiazide, if necessary oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 65 or older
Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg

Exclusion Criteria:

Secondary hypertension
Malignant hypertension
Severe Heart Failure (NYHA III-IV)
Recent history of myocardial infarction
Hypersensitivity to study medications
History of drug or alcohol abuse
History or evidence of renal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751829

Locations

Germany

Munich, Germany

Sponsors and Collaborators

Daiichi Sankyo Europe, GmbH

Investigators

Principal Investigator:

Peter U Witte, MD, Ph.D.

IMFORM GmbH

More Information

No publications provided

Responsible Party:	Daiichi Sankyo Europe, GmbH ( Petra Laeis, Ph.D. )
Study ID Numbers:	SE-866/37
Study First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751829 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Vasodilator Agents
Nitrendipine
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil

Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Nitrendipine
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents

Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009