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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

September 9, 2005
December 12, 2007
May 2005
Not Provided
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
Same as current
Complete list of historical versions of study NCT00185133 on ClinicalTrials.gov Archive Site
  • To evaluate the number (%) of patients achieving BP goal.
  • To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation
Same as current
Not Provided
Not Provided
 
Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
  • Drug: Olmesartan medoxomil
  • Drug: Amlodipine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1900
January 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00185133
CS8663-A-U301
No
Reinilde Heyrman, Daiichi Sankyo
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP