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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872586
• Other study ID #: SS-866 CMB/01
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2009
• Last updated: September 28, 2010
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: September 2010
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.	Shanghai Sankyo Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.		Baseline to12 weeks	No
Secondary	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)	No
Secondary	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)	No
Secondary	The response rate in the two treatment groups from baseline to Week 9		Baseline to 9 weeks	No
Secondary	The response rate in the two treatment groups from baseline to Week 12		Baseline to 12 weeks	No