MedTrace Logo

A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

NCT00791258 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 999

Last updated 2019-01-09

Study results available
· View outcomes & findings →

Summary

The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Conditions

Interventions

DRUG

amlodipine and olmesartan medoxomil tablets

amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks

DRUG

hydrochlorothiazide tablets

hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791258 on ClinicalTrials.gov