Clinical trial NCT01911780: Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
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 Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 132
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+ hydrochlorothiazide 12.5 mg (T80/H12.5 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+ hydrochlorothiazide 12.5 mg.

Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.

In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.

In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.


Eligibility criteria: Inclusion criteria:

1. 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
2. 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
3. Age 20 years or older

Exclusion criteria:

1. Patients with known or suspected secondary hypertension
2. Patients with clinically relevant cardiac arrhythmia
3. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
4. Patients with recent cardiovascular events
5. Patients with recent stroke events
6. 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
7. Patients with hepatic and/or renal dysfunction
8. 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 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
timeFrame: baseline and 8 weeks
measure: The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.
timeFrame: Double-blind and 8 weeks
measure: The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
timeFrame: Reference baseline (week 0) and week 60 (end of extension period)
measure: Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
timeFrame: Reference baseline (week 0) and week 60 (end of extension period)
measure: Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
timeFrame: Reference baseline (week 0) and week 60 (end of extension period)
Other outcomes:
Locations:
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1348.2.020 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Fukuoka, Fukuoka
country: Japan
facility: 1348.2.008 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Kobe, Hyogo
country: Japan
facility: 1348.2.018 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Tokyo
country: Japan
facility: 1348.2.006 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Tokyo
country: Japan
facility: 1348.2.013 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Tokyo
country: Japan
facility: 1348.2.021 Boehringer Ingelheim Investigational Site
city: Hirakata, Osaka
country: Japan
facility: 1348.2.012 Boehringer Ingelheim Investigational Site
city: Kasaoka, Okayama
country: Japan
facility: 1348.2.011 Boehringer Ingelheim Investigational Site
city: Kawasaki, Kanagawa
country: Japan
facility: 1348.2.001 Boehringer Ingelheim Investigational Site
city: Kita-ku, Osaka-shi, Osaka
country: Japan
facility: 1348.2.019 Boehringer Ingelheim Investigational Site
city: Kiyota-ku, Sapporo-shi, Hokkaido
country: Japan
facility: 1348.2.014 Boehringer Ingelheim Investigational Site
city: Kumamoto, Kumamoto
country: Japan
facility: 1348.2.002 Boehringer Ingelheim Investigational Site
city: Nakano-ku,Tokyo
country: Japan
facility: 1348.2.007 Boehringer Ingelheim Investigational Site
city: Nishi-ku, Fukuoka, Fukuoka
country: Japan
facility: 1348.2.009 Boehringer Ingelheim Investigational Site
city: Takatsuki, Osaka
country: Japan
facility: 1348.2.005 Boehringer Ingelheim Investigational Site
city: Uji, Kyoto
country: Japan
facility: 1348.2.016 Boehringer Ingelheim Investigational Site
city: Yoshikawa, Saitama
country: Japan
facility: 1348.2.010 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: