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
  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:


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
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

No publications provided

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 medoxomil
Olmesartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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 July 31, 2014