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NCT Number: NCT00872586

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 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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olmesartan medoxomil + Hydrochlorothiazide

Drug

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

Drug

olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks

Primary outcomes

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

    Time frame: Baseline to12 weeks

Secondary outcomes

  1. 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)

  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

    Time frame: 5 weeks (Week 5 to week 9)

  3. The response rate in the two treatment groups from baseline to Week 9

    Time frame: Baseline to 9 weeks

  4. The response rate in the two treatment groups from baseline to Week 12

    Time frame: Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Shanghai Sankyo Pharmaceuticals Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 31, 2009
Registry last updated
Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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