Trial · NCT01167153
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
NCT01167153, Phase 4, Completed, Novartis; results first posted 2012-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients. Trials, record NCT01167153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01167153
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
- NCT number
- NCT01167153
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 564 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hypertension
- Interventions
- Valsartan/Amlodipine, Nifedipine
- First posted
- 2010-07-22
- Last updated
- 2012-06-01
- Results first posted
- 2012-06-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) | Baseline, 12 weeks | The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis. |
| Primary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks) | Baseline, 12 weeks | The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis. |
| Secondary | Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) | Baseline, 12 weeks | Effective SBP control rate was defined as proportion of subjects in whom MSSBP \< 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline. Effective DBP control rate was defined as proportion of subjects in whom MSDBP \< 90 mmHg or MSDBP reduction ≥10 mmHg from baseline. |
| Secondary | Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks | 12 weeks | Blood Pressure (BP) target was defined as mean sitting BP\<140/90 mm Hg in non-diabetic patients and\<130/80 mm Hg in diabetic patients at 12 weeks. |
| Secondary | Change From Baseline in Orthostatic SBP and DBP at 12 Weeks | Baseline, 12 weeks | The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit. |
| Secondary | Change From Baseline in Sitting Pulse at 12 Weeks | Baseline, 12 weeks | Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit. |
| Secondary | Change From Baseline in Orthostatic Pulse at 12 Weeks | Baseline, 12 weeks | Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) | Baseline, 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline. | mm Hg | MEAN |
| PRIMARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks) | Baseline, 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline. | mm Hg | MEAN |
| SECONDARY | Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) | Baseline, 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks | 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Orthostatic SBP and DBP at 12 Weeks | Baseline, 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Sitting Pulse at 12 Weeks | Baseline, 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline. | beats/min | MEAN |
| SECONDARY | Change From Baseline in Orthostatic Pulse at 12 Weeks | Baseline, 12 weeks | ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline. | beats/min | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) | Valsartan/Amlodipine | -16.8 | Standard Deviation 11.69 | mm Hg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) | Nifedipine | -10.6 | Standard Deviation 12.02 | mm Hg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks) | Valsartan/Amlodipine | -8.5 | Standard Deviation 8.52 | mm Hg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks) | Nifedipine | -4.8 | Standard Deviation 8.89 | mm Hg | |
| Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) | Valsartan/Amlodipine | Achieving Effective SBP Control | 82.40 | Percentage of participants | |
| Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) | Nifedipine | Achieving Effective SBP Control | 63.40 | Percentage of participants | |
| Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) | Valsartan/Amlodipine | Achieving Effective DBP Control | 92.88 | Percentage of participants | |
| Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks) | Nifedipine | Achieving Effective DBP Control | 76.98 | Percentage of participants | |
| Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks | Valsartan/Amlodipine | 79.03 | Percentage of participants | ||
| Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks | Nifedipine | 57.36 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valsartan/Amlodipine | 282 | |
| Overall Study | STARTED | Nifedipine | 282 | |
| Overall Study | Intention to Treat (ITT) | Valsartan/Amlodipine | 272 | |
| Overall Study | Intention to Treat (ITT) | Nifedipine | 268 | |
| Overall Study | COMPLETED | Valsartan/Amlodipine | 264 | |
| Overall Study | COMPLETED | Nifedipine | 249 | |
| Overall Study | NOT COMPLETED | Valsartan/Amlodipine | 18 | |
| Overall Study | NOT COMPLETED | Nifedipine | 33 |
Source ClinicalTrials.gov
Adverse events6
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 | Dizzy | Nervous system disorders | Valsartan/Amlodipine | 11 | 282 | |
| other | Dizzy | Nervous system disorders | Nifedipine | 15 | 282 | |
| other | Headache | Nervous system disorders | Valsartan/Amlodipine | 6 | 282 | |
| other | Headache | Nervous system disorders | Nifedipine | 20 | 282 | |
| serious | Unstable Blood Pressure | Cardiac disorders | Valsartan/Amlodipine | 0 | 282 | |
| serious | Unstable Blood Pressure | Cardiac disorders | Nifedipine | 1 | 282 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valsartan/Amlodipine | ||
| Total, all-cause mortality | Nifedipine | ||
| Total, other adverse events | Valsartan/Amlodipine | 14 | 282 |
| Total, other adverse events | Nifedipine | 32 | 282 |
| Total, serious adverse events | Valsartan/Amlodipine | 0 | 282 |
| Total, serious adverse events | Nifedipine | 1 | 282 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Valsartan/Amlodipine vs Nifedipine: serious adverse events |
Source Trial comparisons
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/NCT01167153
GET https://conductscience.org/api/trials/v1/NCT01167153/registered