NCT00872586

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

11 months

First QC Date

March 27, 2009

Last Update Submit

September 28, 2010

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

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

    Baseline to12 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Olmesartan medoxomil and hydrochlorothiazide

Drug: olmesartan medoxomil + hydrochlorothiazide

2

ACTIVE COMPARATOR

olmesartan medoxomil

Drug: olmesartan medoxomil

Interventions

olmesartan medoxomil + hydrochlorothiazideDRUG

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

1
olmesartan medoxomilDRUG

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

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Wuhan, China

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Olmesartan MedoxomilHydrochlorothiazide

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Naotaka Ikegami, VP

    Shanghai Sankyo Pharmaceuticals Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 31, 2009

Study Start

August 1, 2006

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations

CN(8)