Telmisartan in Mild to Moderate Hypertensive Patients

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Low dose of telmisartan; Drug: High dose of telmisartan; Drug: Placebo

• Registration Number: NCT02260089
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2002-07
• Status Verified: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Study First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex

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Exclusion Criteria

• Suspected or known diagnosis of arterial hypertension with a secondary cause
• Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
• Systolic blood pressure > 200 mm Hg or diastolic blood pressure > 115 mm Hg
• Laboratory test values two fold above the upper normal limit
• Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
• New York Heart Association class III or IV heart failure
• History of stroke in the 6 months prior to entry into the study
• Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels > 140 mg/dL on 3 consecutive assessments
• Patients who were included in another investigational drug study in the past 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose of telmisartan	Low dose of telmisartan	4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
Low dose of telmisartan	Placebo	4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
High dose of telmisartan	High dose of telmisartan	After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg

Primary Outcome Measures

Name	Time	Method
Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)	Baseline, up to 12 weeks after start of treatment	Blood pressure values were obtained 24 hours after the last dose (through values) at the office

Secondary Outcome Measures

Name	Time	Method
Assessment of treatment response for SBP/DBP (in %)	Baseline, up to 12 weeks after start of treatment	Response categories: * SBP \< 140 mm Hg or; * DBP \< 90 mm Hg or; * BP reduction ≥ 10 mm Hg
Changes from baseline in blood pressure values	Baseline, up to 12 weeks after start of treatment	Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup
Number of patients with adverse events	Up to 16 weeks
Number of patients with clinically significant changes in laboratory values	Up to 16 weeks
Number of patients with clinically significant changes in ECG	Up to 16 weeks