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

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

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: olmesartan medoxomil + hydrochlorothiazide; Drug: olmesartan medoxomil

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Chengdu, China
  • Chongqing, China
  • Guang Zhou, China
  • Hang Zhou, China
  • Nanjing, China
  • Shanghai, China
  • Wuhan, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.	Baseline to12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
The response rate in the two treatment groups from baseline to Week 9	Baseline to 9 weeks
The response rate in the two treatment groups from baseline to Week 12	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Shanghai Sankyo Pharmaceuticals Co., Ltd.
• Investigators: Study Director: Naotaka Ikegami, VP, Shanghai Sankyo Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: March 27, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): September 29, 2010
• Last Update Submitted That Met QC Criteria: September 28, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Olmesartan; Olmesartan Medoxomil; Hydrochlorothiazide
• Other Study ID Numbers: SS-866 CMB/01