Telmisartan in Mild to Moderate Hypertensive Patients

NCT02260089 | Completed Phase 4

• 1 other identifier: 502.363
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of treatment response for SBP/DBP (in %)

  Baseline, up to 12 weeks after start of treatment

• Changes from baseline in blood pressure values

  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

Study Arms (2)

Low dose of telmisartan

EXPERIMENTAL

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

Drug: Low dose of telmisartan; Drug: Placebo

High dose of telmisartan

EXPERIMENTAL

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

Interventions

Low dose of telmisartan DRUG

Low dose of telmisartan

High dose of telmisartan DRUG

High dose of telmisartan

Placebo DRUG

Low dose of telmisartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 9, 2014
• Study Start: March 1, 2000
• Primary Completion: July 1, 2002
• Last Updated: October 9, 2014

Record last verified: 2014-10