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SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

NCT00239538 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2013-11-08

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval at the end of a 10-week treatment period in mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus

Conditions

Interventions

DRUG

telmisartan combined with hydrochlorothiazide (80/12.5 mg)

DRUG

valsartan combined with hydrochlorothiazide (160/12.5mg)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim Study Coordinator · B.I. Canada Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Mexico
  • New Zealand
  • South Korea
  • Taiwan

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 NCT00239538 on ClinicalTrials.gov