Trial · NCT03730116
Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril
NCT03730116, Completed, Servier Russia; results first posted 2020-12-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril. Trials, record NCT03730116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03730116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril
- NCT number
- NCT03730116
- Status
- Completed
- Enrollment
- 1,909 participants, actual
- Lead sponsor
- Servier Russia
- Conditions
- Arterial Hypertension, CHD - Coronary Heart Disease
- Interventions
- bisoprolol/perindopril FDC
- First posted
- 2018-11-05
- Last updated
- 2021-01-13
- Results first posted
- 2020-12-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline | 3 months | Changes in the mean office systolic BP levels (in mm Hg) in the sitting position |
| Primary | Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels | 3 month | The percentage of the patients achieved the target levels of clinical BP among included patients ( SBP \< 140 mm Hg and DBP \< 90 mm Hg) with HT and stable CAD recieving Bisoprolol/Perindopril FDC |
| Primary | Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks | 3 month | Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC |
| Primary | Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position | 3 months | Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position among the patints with HT and CAD recieving bis/perindopril FDC |
| Secondary | Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS | 3 month | Changes of the score in the visual analog scale (VAS) to assess the wellbeing; (minimum score 0 mm and maximum score 100 mm) among patients with HT and CAD recieving biso/perindopril FDC |
| Secondary | Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice | 3 month | Percentage of the patients with definite answer on question from questionnaire regarding adherence; (Compliance evaluation test - 6 questions tes; Answer "No" to all questions: good compliance; Answer "Yes" to 1-2 questions: minor compliance; Answer "Yes" to 3 or more questions: noncompliance) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline | 3 months | mm Hg | MEAN | |
| PRIMARY | Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels | 3 month | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks | 3 month | number of angina attacks per week | MEAN | |
| PRIMARY | Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position | 3 months | mm Hg | MEAN | |
| SECONDARY | Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS | 3 month | units on a scale - mm | MEAN | |
| SECONDARY | Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice | 3 month | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline | Mean of SBP Changes | 31.5 | Standard Deviation 14.2 | mm Hg | |
| Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels | the Patients With HT and Concomitant Stable CAD | 1640 | Participants | ||
| Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks | the Patients With HT and Concomitant Stable CAD | -3.2 | Standard Deviation 8.2 | number of angina attacks per week | |
| Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position | Mean Office DBP Changes Between v3 vs Baseline | 15.9 | Standard Deviation 9.5 | mm Hg | |
| Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS | the Patients With HT and Concomitant Stable CAD | 35.1 | Standard Deviation 18.5 | units on a scale - mm | |
| Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice | the Patients With HT and Concomitant Stable CAD | 1827 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Inclusion | STARTED | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| Inclusion | FVFP | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| Inclusion | COMPLETED | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| Inclusion | NOT COMPLETED | the Patients With HT and Concomitant Stable CAD | 0 | |
| 1 Month After Inclusion | STARTED | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| 1 Month After Inclusion | 1 Month After Inclusion | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| 1 Month After Inclusion | COMPLETED | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| 1 Month After Inclusion | NOT COMPLETED | the Patients With HT and Concomitant Stable CAD | 0 | |
| 3 Month After Inclusion | STARTED | the Patients With HT and Concomitant Stable CAD | 1,909 | |
| 3 Month After Inclusion | 3 Month After Inclusion | the Patients With HT and Concomitant Stable CAD | 1,909 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry cough and tingling throat | Respiratory, thoracic and mediastinal disorders | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
| other | A special situation: use of the drug not daily, but as needed | Cardiac disorders | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
| serious | Non-traumatic vertebral compression fracture that required hospitalization | Musculoskeletal and connective tissue disorders | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
| serious | death of unknown caus | Musculoskeletal and connective tissue disorders | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
| serious | Hypotension with dizziness | Cardiac disorders | the Patients With HT and Concomitant Stable CAD | 2 | 1,909 | 2 |
| serious | bradycardia | Product Issues | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
| serious | bradycardia | Cardiac disorders | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
| serious | syncope | Cardiac disorders | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | the Patients With HT and Concomitant Stable CAD | 1 | 1,909 |
| Total, other adverse events | the Patients With HT and Concomitant Stable CAD | 2 | 1,909 |
| Total, serious adverse events | the Patients With HT and Concomitant Stable CAD | 7 | 1,909 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33991323 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03730116
GET https://conductscience.org/api/trials/v1/NCT03730116/registered