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

NCT00326768 | Completed Phase 3

• 1 other identifier: 502.516
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events

  52 weeks

• Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)

  52 weeks

• Changes in electrocardiogram (ECG)

  52 weeks

• Changes in blood pressure and pulse rate

  52 weeks

Secondary Outcomes (7)

• Seated Diastolic Blood Pressure (DBP) control rate

  after 12 and 52 weeks

• Seated Systolic Blood Pressure (SBP) control rate

  after 12 and 52 weeks

• Seated DBP response rate

  after 12 and 52 weeks

• Seated SBP response rate

  after 12 and 52 weeks

• Seated blood pressure (BP) normality criteria

  after 12 and 52 weeks

Interventions

Telmisartan 40 mg/HCTZ 12.5 mg DRUG

Telmisartan 40 mg DRUG

Telmisartan 80 mg/HCTZ 12.5 mg DRUG

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Essential hypertensive patients who meet the following criteria: * In case of using any antihypertensives, mean seated DBP\* must be over 90 and under 114 mmHg at Visit 1 * In case of not using any antihypertensives, mean seated DBP\* must be over 95 and under 114 mmHg at Visit 1 * Mean seated DBP\* must be over 90 at Visit 2 (\* The mean DBP values will be calculated as the average of three seated measurements taken at two-minute intervals). 2. Age over 20 and under 80 years at Visit 1 (Male or Female) 3. Outpatient 4. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications 5. Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law. 1\. Patients taking four or more anti-hypertensive medications at Visit 1 2. Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.) 3. Patients whose mean seated DBP \> 114 mmHg and/or mean seated SBP \> 200 mmHg at Visit 1, Visit 2 or Visit 3 4. Patients with sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (AV-block II-III, atrial fibrillation etc.) 5. Patients with NYHA functional class heart failure III-IV 6. Patients with a history of myocardial infarction or cardiac surgery within last 6 3 months before signing the informed consent form 7. Patients with a history of coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within last 3 months before signing the informed consent form 8. Patients with a history of unstable angina within last 3 months before signing the informed consent form 9. Patients with hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve 10. Patients with a history of stroke or transient ischemic attack within last 6 months before signing the informed consent form 11. Patients with a history of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant 12. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors 13. Patients with known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulfonamide-derived drugs (e.g. thiazides) 14. Known, suspected or history of gout

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (3)

Boehringer Ingelheim Investigational Site

Hiroshima-shi, Hiroshima, 733-0011, Japan

Location

Boehringer Ingelheim Investigational Site

Sapporo-shi, Hokkaido, 060-0003, Japan

Location

Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide

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; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Officials

• Boehringer Ingelheim Study Coordinator

  Nippon Boehringer Ingelheim Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 17, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

JP (3)