A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension
|ClinicalTrials.gov Identifier: NCT02277691|
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : June 26, 2017
Last Update Posted : August 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: TAK-536TCH tablet Drug: TAK-536CCB tablet Drug: HCTZ 12.5 mg tablet||Phase 3|
The drug being tested in this study is called TAK-536TCH. TAK-536TCH is being tested to treat people who have essential hypertension. The study looked at effectiveness and long-term safety of TAK-536TCH in people who took TAK-536CCB in addition to standard care.
The study enrolled 341 patients. Participants received:
- TAK-536CCB (as TAK-536/AML, 20 mg/5 mg) in run-in period,
- TAK-536TCH (as TAK-536/ AML/HCTZ, 20 mg/5 mg/12.5 mg) in treatment period
- TAK-536CCB and HCTZ 12.5 mg in treatment period
All participants were asked to take tablets at the same time each day throughout the study.
This multi-center trial was conducted in Japan. The overall time to participate in this study was 56 weeks (4 weeks run-in period and 52 weeks treatment period). Participants made multiple visits to the clinic during the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||341 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety and Efficacy of TAK-536, Amlodipine and Hydrochlorothiazide in Subjects With Essential Hypertension|
|Actual Study Start Date :||November 7, 2014|
|Actual Primary Completion Date :||April 25, 2016|
|Actual Study Completion Date :||April 25, 2016|
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg orally, once daily, before or after breakfast.
Drug: TAK-536TCH tablet
Drug: TAK-536CCB tablet
Drug: HCTZ 12.5 mg tablet
- Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 52 ]An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
- Number of Participants With Markedly Abnormal Vital Signs Values [ Time Frame: Baseline up to Week 52 ]Vital signs included supine and standing systolic and diastolic blood pressure (SBP and DBP) respectively and office sitting pulse. Vital signs were considered abnormal if they were beyond the values defined in categories.
- Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight [ Time Frame: Baseline up to Week 52 ]Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.
- Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG) [ Time Frame: Baseline up to Week 52 ]Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.
- Number of Participants With Markedly Abnormal Clinical Laboratory Tests [ Time Frame: Baseline up to Week 52 ]The number of participants with any markedly abnormal clinical laboratory test values collected throughout study. RBC = Red blood cells, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit. Laboratory vallues were considered abnormal if they were beyond the values defined in categories.
- Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit [ Time Frame: Baseline (End of Run-in Period, Week 0) and Weeks 12 (LOCF) and 52 (LOCF) ]The change in office trough SBP and DBP measured at Weeks 12 last observation was carried forward (LOCF) and 52 (LOCF) relative to baseline. Sitting blood pressure was measured at least 3 times. Each measurement session ended once blood pressure was found stable at 2 consecutive measurements. The average of the last 2 measurements of office sitting blood pressure was used.
- Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit [ Time Frame: Baseline (End of Run-in Period, Week 0), End of Week 12 and End of Treatment (Up to Week 52) ]The change in home morning SPB and DBP measured at End of Week 12, End of Treatment (Up to Week 52) relative to baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277691
|Nagoya-shi, Aichi, Japan|
|Chiba-shi, Chiba, Japan|
|Itojima-shi, Fukuoka, Japan|
|Kouriyama-shi, Fukushima, Japan|
|Sapporo-shi, Hokkaido, Japan|
|Amagasaki-shi, Hyougo, Japan|
|Tsukuba-shi, Ibaragi, Japan|
|Morioka-shi, Iwate, Japan|
|Sakaide-shi, Kagawa, Japan|
|Takamatsu-shi, Kagawa, Japan|
|Kawasaki-shi, Kanagawa, Japan|
|Kyoto-shi, Kyoto, Japan|
|Uji-shi, Kyoto, Japan|
|Sendai-shi, Miyagi, Japan|
|Hirakata-shi, Osaka, Japan|
|Osaka-shi, Osaka, Japan|
|Takatsuki-shi, Osaka, Japan|
|Saitama-shi, Saitama, Japan|
|Tokorozawa-shi, Saitama, Japan|
|Yaizu-shi, Shizuoka, Japan|
|Chiyoda-ku, Tokyo, Japan|
|Choufu-shi, Tokyo, Japan|
|Kodaira-shi, Tokyo, Japan|
|Koutou-ku, Tokyo, Japan|
|Setagaya-ku, Tokyo, Japan|
|Shinagawa-ku, Tokyo, Japan|
|Shinjuku-ku, Tokyo, Japan|
|Study Director:||Medical Director Clinical Science||Takeda|