Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

NCT01286558 | Completed Phase 3 Results

• 1 other identifier: 1235.37
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 8

Brief Summary

Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended. In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients. Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. 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 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

  Reference baseline, 8 weeks

Secondary Outcomes (12)

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

  Reference baseline, 8 weeks

• Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP

  Reference baseline, 8 weeks

• Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP

  Reference baseline, 8 weeks

• Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP

  Pseudo-baseline, 14 weeks

• Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP

  Pseudo-baseline, 14 weeks

Study Arms (2)

80mg telmisartan and 5mg amlodipine FDC

EXPERIMENTAL

once daily

Drug: 5 mg amlodipine; Drug: 80 mg telmisartan

40mg telmisartan and 5mg amlodipine FDC

ACTIVE COMPARATOR

once daily

Drug: 40 mg telmisartan; Drug: 5 mg amlodipine

Interventions

40 mg telmisartan DRUG

once daily

40mg telmisartan and 5mg amlodipine FDC

5 mg amlodipine DRUG

once daily

80mg telmisartan and 5mg amlodipine FDC

80 mg telmisartan DRUG

once daily

80mg telmisartan and 5mg amlodipine FDC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• 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 (8)

1235.37.01 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, Japan

Location

1235.37.07 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

Location

1235.37.08 Boehringer Ingelheim Investigational Site

Itoshima, Fukuoka, Japan

Location

1235.37.02 Boehringer Ingelheim Investigational Site

Katsushika-ku, Tokyo, Japan

Location

1235.37.05 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1235.37.03 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, Japan

Location

1235.37.06 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1235.37.04 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Amlodipine

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; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

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: January 28, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Last Updated: June 27, 2014
• Results First Posted: October 22, 2012

Record last verified: 2014-01

Locations

JP (8)