Telmisartan 80mg Non-responder Trial

NCT01222520 | Completed Phase 3 Results

• 1 other identifier: 1235.36
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 4

Brief Summary

If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly. In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg. Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough

  Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

  Baseline, 8 weeks

Secondary Outcomes (6)

• Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough

  Baseline, 8 weeks

• Seated DBP Control Rate at Trough

  8 weeks

• Seated SBP Control Rate at Trough

  8 weeks

• Seated DBP Response Rate at Trough

  8 weeks

• Seated SBP Response Rate at Trough

  8 weeks

Study Arms (2)

Telmisartan and amlodipine FDC

EXPERIMENTAL

once a daily

Drug: Telmisartan and amlodipine

Telmisartan monotherapy

ACTIVE COMPARATOR

once a daily

Drug: Telmisartan

Interventions

Telmisartan and amlodipine DRUG

Telmisartan 80 mg and amlodipine 5 mg once a daily

Telmisartan and amlodipine FDC

Telmisartan DRUG

80 mg once a daily

Telmisartan monotherapy

Eligibility Criteria

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

You may qualify if:

• Essential hypertensive patients
• If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be \>=90 and \>=114 mmHg
• If not taking any antihypertensive drugs, mean seated DBP must be \>=95 and \>=114 mmHg
• Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

You may not qualify if:

• Patients taking 3 or more antihypertensive drugs at signing the informed consent form
• Patients with known or suspected secondary hypertension
• Patients with clinically relevant cardiac arrhythmia
• Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
• Patients with recent cardiovascular events
• Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
• Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
• Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
• Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
• Patients with hepatic and/or renal dysfunction
• Pre-menopausal women who are nursing or pregnant

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

1235.36.01 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, Japan

Location

1235.36.04 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

Location

1235.36.02 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1235.36.03 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination; 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

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Last Updated: June 27, 2014
• Results First Posted: July 4, 2012

Record last verified: 2014-01

Locations

JP (4)