Telmisartan in Mild to Moderate Hypertensive Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: High dose of telmisartan; Drug: Placebo; Drug: Low dose of telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260089

502.363

Details and patient eligibility

About

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

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Low dose of telmisartan

Experimental group

Description:

4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan

Treatment:

Drug: Placebo

Drug: Low dose of telmisartan

High dose of telmisartan

Experimental group

Description:

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

Treatment:

Drug: High dose of telmisartan