A Phase 4 interventional study of Group I and Group II in Hypertension, sponsored by HK inno.N Corporation. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by HK inno.N Corporation · Phase 4, Interventional, and Treatment
To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil administered in a fixed-dose combination tablet versus co-administered as their separate formulations in patients with essential hypertension who have shown inadequate response on monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately controlled by co-administration of amlodipine besylate and candesartan cilexetil single agents
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 210 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.
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Diagnosed with essential hypertension
Patients with essential hypertension meeting one of the following two inclusion criteria:
2.1. Patients with essential hypertension who have shown inadequate response (mean siSBP ≥ 140 mmHg or mean siDBP ≥ 90 mmHg) to treatment with amlodipine or candesartan cilexetil.
2.2. Patients with essential hypertension with blood pressure adequately controlled by co-administration of amlodipine besylate and candesartan cilexetil (mean siSBP \< 140 mmHg and mean siDBP \< 90 mmHg).
Exclusion Criteria:
Laboratory abnormalities as follows:
Fixed-Dose combination of Candesartan cilexetil 8mg and Amlodipine 5mg(or Fixed-Dose combination of Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks
Drug: Group I
Candesartan cilexetil 8mg and Amlodipine 5mg(or Candesartan cilexetil 16mg and Amlodipine 5mg), once a day for 8 weeks
Drug: Group II
Machkhan Tab. 8/5 mg + Atacan Tab. 8 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks or Machkhan Tab. 16/5 mg + Atacan Tab. 16 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks
Also known as: Machkhan Tab. 8/5 mg(or Machkhan Tab. 16/5 mg)
Atacan Tab. 8 mg + Norvasc Tab. 5 mg + Machkhan Tab.8/5 mg placebo for 8 weeks or Atacan Tab. 16 mg + Norvasc Tab. 5 mg + Machkhan Tab.16/5 mg placebo for 8 weeks
Also known as: Atacan Tab. 8 mg(or Atacan Tab. 16 mg), Norvasc Tab. 5 mg
Change in sitting Systolic Blood Pressure(siSBP) from baseline after 8 weeks of treatment
For change in siSBP from baseline after 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm. The LS mean change in siSBP from baseline after 8 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 8 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
Time frame: Week 8
Change in siSBP from baseline after 4 weeks of treatment
For change in siSBP from baseline after 4 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm. The LS mean change in siSBP from baseline after 4 weeks of treatment adjusted for baseline siSBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siSBP from baseline after 4 weeks of treatment as response variable and baseline siSBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
Time frame: Week 4
Change in siDBP from baseline after 4 and 8 weeks of treatment
For change in siDBP from baseline after 4 and 8 weeks of treatment, the mean, standard deviation, median, minimum and maximum will be presented by treatment arm. The LS mean change in siSBP from baseline after 4 and 8 weeks of treatment adjusted for baseline siDBP and its standard error will be presented by treatment arm. Non-inferiority test will be conducted using ANCOVA including change in siDBP from baseline after 4 and 8 weeks of treatment as response variable and baseline siDBP and treatment arm as independent variables. Amlodipine besylate/candesartan cilexetil combination tablet will be considered non-inferior to co-administration of amlodipine besylate and candesartan cilexetil if the lower bound of 2-sided 95% CI for the LS mean of difference in siSBP change between the treatment arms is greater than -5.
Time frame: Week 4 and Week 8
Proportion of subjects with siDBP < 90 mmHg and siSBP <140 mmHg after 8 weeks of treatment
The frequency and percentage of subjects with siDBP \< 90 mmHg and the frequency and percentage of subjects with siSBP \< 140 mmHg after 8 weeks of treatment will be presented by treatment arm. Additionally, the frequency and percentage of subjects with both siDBP \< 90 mmHg and siSBP \<140 mmHg after 8 weeks of treatment will be presented by treatment arm. The difference in proportion between treatment arms will be tested using the χ2 test or Fisher's exact test.
Time frame: Week8
Adverse events
All patients treated with the investigational product will be included in the safety analyses. For adverse events, adverse drug reactions and serious adverse events, the number of subjects experiencing the events or reactions, 95% 2-sided CI, incidence rate, and number of the events or reactions will be presented by treatment arm. The difference in the incidence between the treatment arms will be tested using the χ2 test or Fisher's exact test. The incidence and percentage of events by severity, causality, actions taken and outcome will be presented by treatment arm. All AEs will be coded per system organ class (SOC) and preferred term (PT) using the MedDRA; for each coded event, the number and percentage of subjects and the number of cases will be summarized by treatment arm. In addition, for each coded event, the number and percentage of subjects by severity, causality, actions taken and outcome will be presented by treatment arm.
Time frame: Baseline, Week 4 and Week 8
Clinical laboratory tests
For continuous variables in clinical laboratory test items, the mean, standard deviation, minimum and maximum of baseline value, post-baseline values and change form baseline to post-baseline will be presented by treatment arm. The difference in change from baseline to post-baseline between treatment arms will be tested using the unpaired t-test or Wilcoxon's rank sum test depending on the normality. The intra-arm change from baseline to post-baseline will be tested using the paired t-test or Wilcoxon's signed rank test depending on the normality. For categorical variables, the shift table for frequency and percentage will be presented. The difference in the percentage of subjects whose test results changed from 'normal' to 'abnormal' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.
Time frame: Baseline, Wee4 and Week 8
Electrocardiogram (ECG)
For each ECG parameters at baseline and post-baseline, the shift table will be presented with frequency and percentage. The difference in the percentage of subjects whose ECG results changed from 'clinically insignificant' to 'clinically significant' between treatment arms will be tested using the χ2 test or Fisher's exact test. The intra-arm change from baseline to post-baseline will be tested using the McNemar's test.
Time frame: Screening and Week 8
Plan to share: No
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HK inno.N Corporation