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:
Daiichi Sankyo Inc.
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
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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
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 May 23, 2013