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Effects on Ambulatory Arterial stiffness Between a Calcium Channel Blocker and a Diuretics When Used in Combination With Angiotensin II Receptor Blocker in Hypertensive Patients ; AMBLE-AS

Effects on Ambulatory Arterial stiffness Between a Calcium Channel Blocker and a Diuretics When Used in Combination With Angiotensin II Receptor Blocker in Hypertensive Patients ; AMBLE-AS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0003595
Enrollment
90
Registered
2019-03-07
Start date
2019-03-13
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients, who treated hypertensive or durg-naïve hypertensive, undergo run-in period during 4weeks with 20mg dose of olmesartan monotherapy. In order to confirm the patients compliance of the a

Sponsors

Yonsei University, Wonju Severance Christian Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged over 20 years 2) No previous history of cardiovascular disease or Treated hypertensive or drug-naïve hypertensive patients 3) Mean SBP = 140 and/or DBP =90 mmHg

Exclusion criteria

Exclusion criteria: 1) Poor compliance of ambulatory monitoring device during run-in period 2) pregnant women, possible candidate for pregnancy or breast feeding females 3) known or suspected secondary hypertension 4) mean seated SBP = 180mmHg and/or mean seated DBP = 120mmHg at any visit 5) any clinically significant hepatic impairment 6) severe renal impairment (serum creatinine >2.0mg/dl) 7) bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant 8) clinically relevant hyperkalemia 9) uncorrected volume or sodium depletion 10) primary aldosteronism 11) symptomatic congestive heart failure 12) concurrent participation in another clinical trial 13) patients with known intolerance, contraindiciation or hypersensitivity to any component of dihydropyridines, angiotensin receptor blocker 14) patients who is judged not to be adequate by the investigator

Design outcomes

Primary

MeasureTime frame
24hr ambulatory mean pulse wave velocity

Secondary

MeasureTime frame
Change of 24hr ambulatory mean pulse wave velocity from randomization to 24wks;24hrs ambulatory morning, day, night pulse wave velocity at 24wks;Change of 24hr ambulatory morning, day, night pulse wave velocity from randomization to 24wks;24hr CBP (central blood pressure) at 24 wks;Change of 24hr CBP from randomization to24 wks;24hr AI (augmentation Index) at 24 wks;Change of 24hr AI from randomization to 24 wks;Ambulatory arterial stiffness index at 24 kws;Change of ambulatory arterial stiffness index from randomization to 24 wks;Change of microalbuminuria from randomization to 24 wks

Countries

Korea, Republic of

Contacts

Public ContactByungsu Yoo

Yonsei University, Wonju Severance Christian Hospital

byungsuyoo@gmail.com+82-33-741-0908

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026