Add-on to Micamlo BP Trial

Hypertension Clinical Trial

Official title:

An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 5 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975246
• Other study ID #: 1348.1
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2013
• Last updated: July 23, 2014
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

• Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg

• Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion

• Age 20 years or older

Exclusion criteria:

• 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 recent stroke events

• Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy

• Patients with hepatic and/or renal dysfunction

• Pre-menopausal women who are nursing or pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan + amlodipine
FDC tablet
• hydrochlorothiazide
tablet
• Telmisartan + amlodipine
FDC tablet
• Placebo
placebo matching hydrochlorothiazide tablet

Locations

Country	Name	City	State
Japan	1348.1.015 Boehringer Ingelheim Investigational Site	Atsubetsu-ku,Sapporo,Hokkaido
Japan	1348.1.006 Boehringer Ingelheim Investigational Site	Bunkyo-ku, Tokyo
Japan	1348.1.002 Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	1348.1.005 Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	1348.1.031 Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	1348.1.030 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1348.1.033 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1348.1.016 Boehringer Ingelheim Investigational Site	Chuo-ku,Sapporo,Hokkaido
Japan	1348.1.021 Boehringer Ingelheim Investigational Site	Chuo-ku,Tokyo
Japan	1348.1.024 Boehringer Ingelheim Investigational Site	Itabashi-ku, Tokyo
Japan	1348.1.028 Boehringer Ingelheim Investigational Site	Itoshima, Fukuoka
Japan	1348.1.027 Boehringer Ingelheim Investigational Site	Katsushika-ku, Tokyo
Japan	1348.1.001 Boehringer Ingelheim Investigational Site	Kishiwada, Osaka
Japan	1348.1.009 Boehringer Ingelheim Investigational Site	Kita-ku, Osaka
Japan	1348.1.029 Boehringer Ingelheim Investigational Site	Kita-ku, Osaka
Japan	1348.1.014 Boehringer Ingelheim Investigational Site	Kiyose,Tokyo
Japan	1348.1.003 Boehringer Ingelheim Investigational Site	Koto-ku, Tokyo
Japan	1348.1.022 Boehringer Ingelheim Investigational Site	Mihama-ku, Chiba, Chiba
Japan	1348.1.004 Boehringer Ingelheim Investigational Site	Miyagino-ku, Sendai, Miyagi
Japan	1348.1.017 Boehringer Ingelheim Investigational Site	Moriya, Ibaraki
Japan	1348.1.013 Boehringer Ingelheim Investigational Site	Naka-ku,Yokohama,Kanagawa
Japan	1348.1.018 Boehringer Ingelheim Investigational Site	Nishi-ku, Fukuoka, Fukuoka
Japan	1348.1.007 Boehringer Ingelheim Investigational Site	Okinawa, Okinawa
Japan	1348.1.020 Boehringer Ingelheim Investigational Site	Sakaide, Kagawa
Japan	1348.1.025 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1348.1.026 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1348.1.008 Boehringer Ingelheim Investigational Site	Suita, Osaka
Japan	1348.1.032 Boehringer Ingelheim Investigational Site	Suita, Osaka
Japan	1348.1.019 Boehringer Ingelheim Investigational Site	Takamatsu, Kagawa
Japan	1348.1.023 Boehringer Ingelheim Investigational Site	Toshima-ku, Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period		baseline and week 8	No
Secondary	Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period		baseline and week 8	No
Secondary	The proportion of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period		baseline and week 8	No