Amlodipine as Add-on to Olmesartan in Hypertension

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00220220

First Posted: September 22, 2005

Last Update Posted: October 11, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Daiichi Sankyo, Inc.

Purpose

Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.

Condition	Intervention	Phase
Essential Hypertension	Drug: olmesartan medoxomil Drug: amlodipine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Amlodipine Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy

Resource links provided by NLM:

Drug Information available for: Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:

Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.

Secondary Outcome Measures:

Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
Safety and tolerability


Estimated Enrollment:	429
Study Start Date:	April 2005
Study Completion Date:	April 2007

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.

Exclusion Criteria:

Secondary hypertension of any aetiology;
Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220220

Locations


Germany

Hamburg, Germany

Magdeburg, Germany

Messkirch, Germany

Stuhr, Germany

Tann, Germany

Worpswede, Germany

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators


Principal Investigator:	Peter Brommer, MD

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barrios V, Brommer P, Haag U, Calderón A, Escobar C. Olmesartan medoxomil plus amlodipine increases efficacy in patients with moderate-to-severe hypertension after monotherapy: a randomized, double-blind, parallel-group, multicentre study. Clin Drug Investig. 2009;29(7):427-39. doi: 10.2165/00044011-200929070-00001.


ClinicalTrials.gov Identifier:	NCT00220220 History of Changes
Other Study ID Numbers:	CS8663-A-E302
First Submitted:	September 16, 2005
First Posted:	September 22, 2005
Last Update Posted:	October 11, 2007
Last Verified:	October 2007

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Olmesartan Amlodipine Olmesartan Medoxomil Antihypertensive Agents	Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists

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