Telmisartan in Mild to Moderate Hypertensive Patients

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Low dose of telmisartan
* Drug: High dose of telmisartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose of telmisartan<br>4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan | Drug: Low dose of telmisartan<br> <br> Drug: Placebo<br> <br> |
| Experimental: High dose of telmisartan<br>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 | Drug: High dose of telmisartan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment response for SBP/DBP (in %) | Response categories: SBP < 140 mm Hg or DBP < 90 mm Hg or BP reduction ≥ 10 mm Hg | Baseline, up to 12 weeks after start of treatment | 
| Changes from baseline in blood pressure values | Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup | Baseline, up to 12 weeks after start of treatment | 
| 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 |