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:
Collaborator:
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00872586
First received: March 27, 2009
Last updated: September 28, 2010
Last verified: September 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • The response rate in the two treatment groups from baseline to Week 9 [ Time Frame: Baseline to 9 weeks ] [ Designated as safety issue: No ]
  • The response rate in the two treatment groups from baseline to Week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: March 27, 2009
Last Updated: September 28, 2010
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 26, 2014