A Phase 2 interventional study of Candesartan Cilexetil 8mg and Candesartan Cilexetil 16mg in Essential Hypertension, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 23 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-11-22.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 392 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women who is planning to be pregnant during or 2 months after the study, or women or men who are not using medically acceptable methods of contraception *
* progestin oral or implant contraceptive, intra-uterine device, condom, partner with surgical sterilization, etc.
Candesartan Cilexetil 8mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg
Candesartan Cilexetil 16mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 16mg
Amlodipine 5mg, once a day for 8 weeks
Drug: Amlodipine 5mg
Amlodipine 10mg, once a day for 8 weeks
Drug: Amlodipine 10mg
Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg · Drug: Amlodipine 5mg
Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 8mg · Drug: Amlodipine 10mg
Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 16mg · Drug: Amlodipine 5mg
Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
Drug: Candesartan Cilexetil 16mg · Drug: Amlodipine 10mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Also known as: Atacand 8mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Also known as: Atacand 16mg
Amlodipine 5mg Daily oral administration for 8 weeks
Also known as: Norvasc 5mg
Amlodipine 10mg Daily oral administration for 8 weeks
Also known as: Norvasc 10mg
Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline
Time frame: Week 8
Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline
Time frame: Week 4
Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline
Time frame: Week 4 and 8
Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg
Joint National Committee VII Guideline Treatment goal: \< 140/90 mmHg (\< 130/80 mmHg, diabetic or chronic renal failure patient)
Time frame: Week 4 and 8
Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg
Time frame: Week 4 and 8
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shin Poong Pharmaceutical Co. Ltd.