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

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00872586
• Collaborator: Shanghai Sankyo Pharmaceuticals Co., Ltd. (Other)
• Enrollment: 304
• Locations: 8
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 38
• Patients Per Site Per Month: 3.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide; Drug: olmesartan medoxomil	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• 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
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups. [Baseline to12 weeks]

Secondary Outcome Measures

1. The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups [8 weeks (week 5 to week 12)]

2. 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 [5 weeks (Week 5 to week 9)]

3. The response rate in the two treatment groups from baseline to Week 9 [Baseline to 9 weeks]

4. The response rate in the two treatment groups from baseline to Week 12 [Baseline to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Beijing		China
2		Chengdu		China
3		Chongqing		China
4		Guang Zhou		China
5		Hang Zhou		China
6		Nanjing		China
7		Shanghai		China
8		Wuhan		China

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• Shanghai Sankyo Pharmaceuticals Co., Ltd.

Investigators

• Study Director: Naotaka Ikegami, VP, Shanghai Sankyo Pharmaceuticals Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00872586
• Other Study ID Numbers: SS-866 CMB/01
• First Posted: Mar 31, 2009
• Last Update Posted: Sep 29, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Study Results

No Results Posted as of Sep 29, 2010