Clinical trial NCT01975246: Add-on to Micamlo BP 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-11-03
Enrollment: 309
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
timeFrame: baseline and week 8
Secondary outcomes:
measure: Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
timeFrame: baseline and week 8
measure: 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
timeFrame: baseline and week 8
Other outcomes:
Locations:
city: Atsubetsu-ku,Sapporo,Hokkaido
country: Japan
facility: 1348.1.015 Boehringer Ingelheim Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: 1348.1.006 Boehringer Ingelheim Investigational Site
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1348.1.002 Boehringer Ingelheim Investigational Site
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1348.1.005 Boehringer Ingelheim Investigational Site
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1348.1.031 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1348.1.030 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1348.1.033 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Sapporo,Hokkaido
country: Japan
facility: 1348.1.016 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Tokyo
country: Japan
facility: 1348.1.021 Boehringer Ingelheim Investigational Site
city: Itabashi-ku, Tokyo
country: Japan
facility: 1348.1.024 Boehringer Ingelheim Investigational Site
city: Itoshima, Fukuoka
country: Japan
facility: 1348.1.028 Boehringer Ingelheim Investigational Site
city: Katsushika-ku, Tokyo
country: Japan
facility: 1348.1.027 Boehringer Ingelheim Investigational Site
city: Kishiwada, Osaka
country: Japan
facility: 1348.1.001 Boehringer Ingelheim Investigational Site
city: Kita-ku, Osaka
country: Japan
facility: 1348.1.009 Boehringer Ingelheim Investigational Site
city: Kita-ku, Osaka
country: Japan
facility: 1348.1.029 Boehringer Ingelheim Investigational Site
city: Kiyose,Tokyo
country: Japan
facility: 1348.1.014 Boehringer Ingelheim Investigational Site
city: Koto-ku, Tokyo
country: Japan
facility: 1348.1.003 Boehringer Ingelheim Investigational Site
city: Mihama-ku, Chiba, Chiba
country: Japan
facility: 1348.1.022 Boehringer Ingelheim Investigational Site
city: Miyagino-ku, Sendai, Miyagi
country: Japan
facility: 1348.1.004 Boehringer Ingelheim Investigational Site
city: Moriya, Ibaraki
country: Japan
facility: 1348.1.017 Boehringer Ingelheim Investigational Site
city: Naka-ku,Yokohama,Kanagawa
country: Japan
facility: 1348.1.013 Boehringer Ingelheim Investigational Site
city: Nishi-ku, Fukuoka, Fukuoka
country: Japan
facility: 1348.1.018 Boehringer Ingelheim Investigational Site
city: Okinawa, Okinawa
country: Japan
facility: 1348.1.007 Boehringer Ingelheim Investigational Site
city: Sakaide, Kagawa
country: Japan
facility: 1348.1.020 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1348.1.025 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1348.1.026 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1348.1.008 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1348.1.032 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 1348.1.019 Boehringer Ingelheim Investigational Site
city: Toshima-ku, Tokyo
country: Japan
facility: 1348.1.023 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: