A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension

A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension - HOPE-Combi survey

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037536

Enrollment

2200

Registered

2019-07-30

Start date

2014-10-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hypertension

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hypertensive patients who newly started administering ATEDIO Combination Tablet

Exclusion criteria

Exclusion criteria: 1) Violation of registration criteria 2) Lost to follow up after initial visit 3) Not administered

Design outcomes

Primary

Measure	Time frame
Safety Incidence of adverse drug reactions Efficacy 1) Changes in office or home blood pressure levels and pulse rate 2) Changes in office blood pressure from baseline to study end (baseline, 3, 6, 9 and 12 months) 3) Changes in office pulse rate from baseline to study end (baseline, 3, 6, 9 and 12 months) 4) Changes in office pulse rate in relation to baseline office pulse rate: all, 75 or more but less than 85 beats/min, 85 beats/min or more 5) Changes in the percentage of patients categorized by office blood pressure and home blood pressure ate at baseline and after 12 months (normotension: less than 135 mmHg of home blood pressure and less than 140 mmHg of office blood pressure, hypertension: 135 mmHg or more of home blood pressure and 140 mmHg or more of office blood pressure, masked hypertension: 135 mmHg or more of home blood pressure and less than140 mmHg of office blood pressure, white cote hypertension: less than 135 mmHg of home blood pressure and 140 mmHg or more of office blood pressure) 6) The proportions of patients achieved the OBP targets BP were investigated according to the target BP level in JSH 2019 or JSH 2014	—

Measure

Time frame

Safety Incidence of adverse drug reactions Efficacy 1) Changes in office or home blood pressure levels and pulse rate 2) Changes in office blood pressure from baseline to study end (baseline, 3, 6, 9 and 12 months) 3) Changes in office pulse rate from baseline to study end (baseline, 3, 6, 9 and 12 months) 4) Changes in office pulse rate in relation to baseline office pulse rate: all, 75 or more but less than 85 beats/min, 85 beats/min or more 5) Changes in the percentage of patients categorized by office blood pressure and home blood pressure ate at baseline and after 12 months (normotension: less than 135 mmHg of home blood pressure and less than 140 mmHg of office blood pressure, hypertension: 135 mmHg or more of home blood pressure and 140 mmHg or more of office blood pressure, masked hypertension: 135 mmHg or more of home blood pressure and less than140 mmHg of office blood pressure, white cote hypertension: less than 135 mmHg of home blood pressure and 140 mmHg or more of office blood pressure) 6) The proportions of patients achieved the OBP targets BP were investigated according to the target BP level in JSH 2019 or JSH 2014

—

Secondary

Measure	Time frame
Sub-analysis 1: Morning home blood pressure and pulse pressure 1) Changes in morning home blood pressure, pulse pressure and pulse rate from baseline to study end (baseline, 3, 6, 9 and 12 months) 2) Changes in morning home systolic blood pressure in 2 categories of baseline morning pulse rate: less than 70 beats/min, 70 beats /min or more (baseline, 3, 6, 9 and 12 months) 3) Scatter plot of the linear relationship between the baseline morning home systolic blood pressure and the change in morning home systolic blood pressure: baseline and after 3 months, baseline and after 12 months 4) Time course of morning home pulse pressure (quantile of pulse pressure) at morning home pulse rate: less than 70 bpm, 70 bpm or more (baseline, 3, 6, 9 and 12 months) Sub-analysis 2: Day-by-day variability of morning home systolic blood pressure 1) Time course of morning systolic blood pressure and parameters of variability of morning systolic blood pressure (baseline, 3 and 12 months) 2) Time course of morning systolic blood pressure and parameters of variability of morning systolic blood pressure by age: less than 70 years, 70 years or more (baseline, 3 and 12 months)	—

Measure

Time frame

Sub-analysis 1: Morning home blood pressure and pulse pressure 1) Changes in morning home blood pressure, pulse pressure and pulse rate from baseline to study end (baseline, 3, 6, 9 and 12 months) 2) Changes in morning home systolic blood pressure in 2 categories of baseline morning pulse rate: less than 70 beats/min, 70 beats /min or more (baseline, 3, 6, 9 and 12 months) 3) Scatter plot of the linear relationship between the baseline morning home systolic blood pressure and the change in morning home systolic blood pressure: baseline and after 3 months, baseline and after 12 months 4) Time course of morning home pulse pressure (quantile of pulse pressure) at morning home pulse rate: less than 70 bpm, 70 bpm or more (baseline, 3, 6, 9 and 12 months) Sub-analysis 2: Day-by-day variability of morning home systolic blood pressure 1) Time course of morning systolic blood pressure and parameters of variability of morning systolic blood pressure (baseline, 3 and 12 months) 2) Time course of morning systolic blood pressure and parameters of variability of morning systolic blood pressure by age: less than 70 years, 70 years or more (baseline, 3 and 12 months)

—

Countries

Japan

Contacts

Public ContactSaori Matsuda

EA Pharma Co., Ltd. Post-Marketing Medical Research Group, Medical Dept.

saori_matsuda@eapharma.co.jp03-6280-9512

Outcome results