Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00185133

First received: September 9, 2005

Last updated: December 12, 2007

Last verified: December 2007

History of Changes

Purpose

This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Condition	Intervention	Phase
Hypertension	Drug: Olmesartan medoxomil Drug: Amlodipine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Factorial Study Evaluating the Efficacy and Safety of co-Administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension

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:

Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary Outcome Measures:

To evaluate the number (%) of patients achieving BP goal.
To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation


Estimated Enrollment:	1900
Study Start Date:	May 2005
Estimated Study Completion Date:	January 2007

Eligibility


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

Criteria

Inclusion Criteria:

Male or female patients
18 years of age or older (20% equal to or older than 65 years)
With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion Criteria:

Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185133

Show 139 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information


Responsible Party:	Reinilde Heyrman, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00185133 History of Changes
Other Study ID Numbers:	CS8663-A-U301
Study First Received:	September 9, 2005
Last Updated:	December 12, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:


Treatment of high blood pressure in mild to severe hypertensive patients

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

ClinicalTrials.gov processed this record on September 23, 2016

To Top