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

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Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Essential Hypertension

Treatments

Drug: olmesartan medoxomil
Drug: olmesartan medoxomil + hydrochlorothiazide

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT00872586
SS-866 CMB/01

Details and patient eligibility

About

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

Enrollment

304 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

304 participants in 2 patient groups

1
Experimental group
Description:
Olmesartan medoxomil and hydrochlorothiazide
Treatment:
Drug: olmesartan medoxomil + hydrochlorothiazide
2
Active Comparator group
Description:
olmesartan medoxomil
Treatment:
Drug: olmesartan medoxomil

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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