OSCAR: Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00139698

Collaborator

(none)

410

Enrollment

Locations

Duration (Months)

12.8

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: olmesartan alone or in combination with hydrochlorothiazide	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III, Multicenter, Open-Label, Dose-Titrating, 16-Week Study Evaluating The Efficacy, Tolerability and Safety of Olmesartan Medoxomil 20 Mg and 40 Mg Alone or in Combination With 12.5 Mg to 25 Mg of Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

Study Start Date :

Sep 1, 2005

Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has mild to moderate hypertension

Exclusion Criteria:

History of secondary hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Medellin	Antioquia	Colombia
2	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia
3	Pfizer Investigational Site	Cartagena	Atlantico	Colombia
4	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
5	Pfizer Investigational Site	Cali	Valle Del Cauca	Colombia
6	Pfizer Investigational Site	Escobedo	Guayas	Ecuador
7	Pfizer Investigational Site	Quito	Pichincha	Ecuador
8	Pfizer Investigational Site	NT		Hong Kong
9	Pfizer Investigational Site	Shatin, NT		Hong Kong
10	Pfizer Investigational Site	Jakarta		Indonesia	10430
11	Pfizer Investigational Site	Jakarta		Indonesia	11420
12	Pfizer Investigational Site	Jakarta		Indonesia
13	Pfizer Investigational Site	Surabaya		Indonesia	60286
14	Pfizer Investigational Site	Seremban	Negeri Sembilan	Malaysia	70300
15	Pfizer Investigational Site	Kuching	Sarawak	Malaysia	93586
16	Pfizer Investigational Site	San Juan	Metro Manila	Philippines
17	Pfizer Investigational Site	Quezon		Philippines
18	Pfizer Investigational Site	Singapore		Singapore	119074
19	Pfizer Investigational Site	Singapore		Singapore	169608
20	Pfizer Investigational Site	Guei-Shan Shiang	Tau-Yuan Shian	Taiwan	333
21	Pfizer Investigational Site	Kaohsiung		Taiwan	813
22	Pfizer Investigational Site	Taipei		Taiwan	106
23	Pfizer Investigational Site	Taipei		Taiwan	112
24	Pfizer Investigational Site	Khet Rajathevee	Bangkok	Thailand	10400
25	Pfizer Investigational Site	Bangkok		Thailand	10400
26	Pfizer Investigational Site	Bangkok		Thailand	10700
27	Pfizer Investigational Site	Chiang Mai		Thailand	50200
28	Pfizer Investigational Site	Bornova/Izmir		Turkey	35100
29	Pfizer Investigational Site	Haseki/Istanbul		Turkey	34390
30	Pfizer Investigational Site	Sihhiye/Ankara		Turkey	06100
31	Pfizer Investigational Site	SÂ¿hhiye/Ankara		Turkey	06100
32	Pfizer Investigational Site