Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00326768
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.

Detailed Description

This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study.

Study Hypothesis:

The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed.

Comparison(s):

This study has no control group.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-16
• Study First Submitted QC: 2006-05-16
• Study First Posted: 2006-05-17
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in blood pressure and pulse rate	52 weeks
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)	52 weeks
Incidence of adverse events	52 weeks
Changes in electrocardiogram (ECG)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Seated DBP response rate	after 12 and 52 weeks
Seated SBP response rate	after 12 and 52 weeks
Changes in seated DBP	after 12 and 52 weeks
Changes in seated SBP	after 12 and 52 weeks
Seated blood pressure (BP) normality criteria	after 12 and 52 weeks
Seated Diastolic Blood Pressure (DBP) control rate	after 12 and 52 weeks
Seated Systolic Blood Pressure (SBP) control rate	after 12 and 52 weeks

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan