NCT00139698

Brief Summary

Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Trial Health

98
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
10 countries

31 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

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

First QC Date

August 29, 2005

Last Update Submit

December 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Secondary Outcomes (1)

  • Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Interventions

Eligibility Criteria

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

You may qualify if:

  • Subject has mild to moderate hypertension

You may not qualify if:

  • History of secondary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Pfizer Investigational Site

Medellín, Antioquia, Colombia

Location

Pfizer Investigational Site

Barranquilla, Atlántico, Colombia

Location

Pfizer Investigational Site

Cartagena, Atlántico, Colombia

Location

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Location

Pfizer Investigational Site

Cali, Valle del Cauca Department, Colombia

Location

Pfizer Investigational Site

Escobedo, Guayas, Ecuador

Location

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Location

Pfizer Investigational Site

NT, Hong Kong

Location

Pfizer Investigational Site

Shatin, NT, Hong Kong

Location

Pfizer Investigational Site

Jakarta, 10430, Indonesia

Location

Pfizer Investigational Site

Jakarta, 11420, Indonesia

Location

Pfizer Investigational Site

Jakarta, Indonesia

Location

Pfizer Investigational Site

Surabaya, 60286, Indonesia

Location

Pfizer Investigational Site

Seremban, Negeri Sembilan, 70300, Malaysia

Location

Pfizer Investigational Site

Kuching, Sarawak, 93586, Malaysia

Location

Pfizer Investigational Site

San Juan City, National Capital Region, Philippines

Location

Pfizer Investigational Site

Quezon, Philippines

Location

Pfizer Investigational Site

Singapore, 119074, Singapore

Location

Pfizer Investigational Site

Singapore, 169608, Singapore

Location

Pfizer Investigational Site

Guei-Shan Shiang, Tau-Yuan Shian, 333, Taiwan

Location

Pfizer Investigational Site

Kaohsiung City, 813, Taiwan

Location

Pfizer Investigational Site

Taipei, 106, Taiwan

Location

Pfizer Investigational Site

Taipei, 112, Taiwan

Location

Pfizer Investigational Site

Khet Rajathevee, Bangkok, 10400, Thailand

Location

Pfizer Investigational Site

Bangkok, 10400, Thailand

Location

Pfizer Investigational Site

Bangkok, 10700, Thailand

Location

Pfizer Investigational Site

Chiang Mai, 50200, Thailand

Location

Pfizer Investigational Site

Bornova/Izmir, 35100, Turkey (Türkiye)

Location

Pfizer Investigational Site

Haseki/Istanbul, 34390, Turkey (Türkiye)

Location

Pfizer Investigational Site

S¿hhiye/Ankara, 06100, Turkey (Türkiye)

Location

Pfizer Investigational Site

Sihhiye/Ankara, 06100, Turkey (Türkiye)

Location

Pfizer Investigational Site

Location

Related Links

MeSH Terms

Conditions

Essential Hypertension

Interventions

olmesartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

September 1, 2005

Study Completion

July 1, 2006

Last Updated

December 5, 2018

Record last verified: 2018-12

Locations