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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872586
First Posted: March 31, 2009
Last Update Posted: September 29, 2010
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.
Collaborator:
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
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

Condition Intervention Phase
Essential Hypertension Drug: olmesartan medoxomil + hydrochlorothiazide Drug: olmesartan medoxomil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 Measures:
  • 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) ]
  • 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) ]
  • The response rate in the two treatment groups from baseline to Week 9 [ Time Frame: Baseline to 9 weeks ]
  • The response rate in the two treatment groups from baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]

Enrollment: 304
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Olmesartan medoxomil and hydrochlorothiazide
Drug: olmesartan medoxomil + hydrochlorothiazide
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
Active Comparator: 2
olmesartan medoxomil
Drug: olmesartan medoxomil
olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT00872586


Locations
China
Beijing, China
Chengdu, China
Chongqing, China
Guang Zhou, China
Hang Zhou, China
Nanjing, China
Shanghai, China
Wuhan, China
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Investigators
Study Director: Naotaka Ikegami, VP Shanghai Sankyo Pharmaceuticals Co., Ltd.
  More Information

Responsible Party: Naotaka Ikegami, Vice President, Shanghai Sankyo Pharmaceuticals, Co., Ltd.
ClinicalTrials.gov Identifier: NCT00872586     History of Changes
Other Study ID Numbers: SS-866 CMB/01
First Submitted: March 27, 2009
First Posted: March 31, 2009
Last Update Posted: September 29, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Hydrochlorothiazide
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists