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Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
olmesartan medoxomil + hydrochlorothiazide
olmesartan medoxomil
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and < 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and < 180 mmHg
  • At Visit 4, mean SeDBP ≥ 90 mmH
  • No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system

Exclusion Criteria:

  • Patients with known or suspect secondary hypertension
  • Unstable angina
  • History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study
  • Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease
  • Arrhythmia of clinical significance
  • Bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation
  • Acute glomerular nephritis
  • Gout sufferers, even with the normal serum uric acid at entry
  • Retinal hemorrhage /exudate
  • Type 1 diabetes mellitus
  • Uncontrolled type 2 diabetes mellitus
  • Hypovolemia
  • Patients with autoimmune disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Olmesartan medoxomil and hydrochlorothiazide

olmesartan medoxomil

Outcomes

Primary Outcome Measures

Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.

Secondary Outcome Measures

The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups
The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups
The response rate in the two treatment groups from baseline to Week 9
The response rate in the two treatment groups from baseline to Week 12

Full Information

First Posted
March 27, 2009
Last Updated
September 28, 2010
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Shanghai Sankyo Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00872586
Brief Title
Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension
Official Title
A Randomized, Double-blind, Double-dummy, Multicenter Clinical Trial to Evaluate the Additional Efficacy and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension, Who Fail to Attain the Blood Pressure Goals With Olmesartan Medoxomil 20mg Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Shanghai Sankyo Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Olmesartan medoxomil and hydrochlorothiazide
Arm Title
2
Arm Type
Active Comparator
Arm Description
olmesartan medoxomil
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil + hydrochlorothiazide
Intervention Description
olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks
Primary Outcome Measure Information:
Title
Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
Time Frame
Baseline to12 weeks
Secondary Outcome Measure Information:
Title
The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups
Time Frame
8 weeks (week 5 to week 12)
Title
The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups
Time Frame
5 weeks (Week 5 to week 9)
Title
The response rate in the two treatment groups from baseline to Week 9
Time Frame
Baseline to 9 weeks
Title
The response rate in the two treatment groups from baseline to Week 12
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and < 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and < 180 mmHg At Visit 4, mean SeDBP ≥ 90 mmH No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system Exclusion Criteria: Patients with known or suspect secondary hypertension Unstable angina History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease Arrhythmia of clinical significance Bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation Acute glomerular nephritis Gout sufferers, even with the normal serum uric acid at entry Retinal hemorrhage /exudate Type 1 diabetes mellitus Uncontrolled type 2 diabetes mellitus Hypovolemia Patients with autoimmune disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naotaka Ikegami, VP
Organizational Affiliation
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
City
Chengdu
Country
China
City
Chongqing
Country
China
City
Guang Zhou
Country
China
City
Hang Zhou
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
City
Wuhan
Country
China

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension

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