Trial · NCT00413413
Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
NCT00413413, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2009-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension. Trials, record NCT00413413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413413
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
- NCT number
- NCT00413413
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,134 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- Valsartan/amlodipine 80/5 mg, Valsartan 80 mg, Valsartan 160 mg
- First posted
- 2006-12-19
- Last updated
- 2011-04-28
- Results first posted
- 2009-09-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. |
| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. |
| Secondary | Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | Baseline to end of study (Week 8) | A diastolic blood pressure response was defined as a msDBP \< 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. |
| Secondary | Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Diastolic blood pressure control was defined as a msDBP \< 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. |
| Secondary | Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Overall blood pressure control rate was defined as a msSBP/msDBP \< 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | Baseline to end of study (Week 8) | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Valsartan/Amlodipine 80/5 mg | -10.8 | Standard Error 0.42 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Valsartan 80 mg | -6.3 | Standard Error 0.42 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Valsartan 160 mg | -7.2 | Standard Error 0.42 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Valsartan/Amlodipine 80/5 mg | -12.5 | Standard Error 0.61 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Valsartan 80 mg | -6.0 | Standard Error 0.62 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Valsartan 160 mg | -7.7 | Standard Error 0.62 | mmHg | |
| Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | Valsartan/Amlodipine 80/5 mg | 77.9 | Percentage of patients | ||
| Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | Valsartan 80 mg | 57.8 | Percentage of patients | ||
| Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | Valsartan 160 mg | 66.6 | Percentage of patients | ||
| Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) | Valsartan/Amlodipine 80/5 mg | 74.4 | Percentage of patients |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-Blind | STARTED | Valsartan/Amlodipine 80/5 mg | 0 | |
| Single-Blind | STARTED | Valsartan 80 mg | 1,134 | |
| Single-Blind | STARTED | Valsartan 160 mg | 0 | |
| Single-Blind | COMPLETED | Valsartan/Amlodipine 80/5 mg | 0 | |
| Single-Blind | COMPLETED | Valsartan 80 mg | 918 | |
| Single-Blind | COMPLETED | Valsartan 160 mg | 0 | |
| Single-Blind | NOT COMPLETED | Valsartan/Amlodipine 80/5 mg | 0 | |
| Single-Blind | NOT COMPLETED | Valsartan 80 mg | 216 | |
| Single-Blind | NOT COMPLETED | Valsartan 160 mg | 0 | |
| Double-Blind | STARTED | Valsartan/Amlodipine 80/5 mg | 308 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events18
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 |
|---|---|---|---|---|---|---|
| serious | Leukopenia | Blood and lymphatic system disorders | Valsartan/Amlodipine 80/5 mg | 0 | 308 | |
| serious | Leukopenia | Blood and lymphatic system disorders | Valsartan 80 mg | 0 | 307 | |
| serious | Leukopenia | Blood and lymphatic system disorders | Valsartan 160 mg | 1 | 303 | |
| serious | Retinal haemorrhage | Eye disorders | Valsartan/Amlodipine 80/5 mg | 1 | 308 | |
| serious | Retinal haemorrhage | Eye disorders | Valsartan 80 mg | 0 | 307 | |
| serious | Retinal haemorrhage | Eye disorders | Valsartan 160 mg | 0 | 303 | |
| serious | Abdominal injury | Injury, poisoning and procedural complications | Valsartan/Amlodipine 80/5 mg | 1 | 308 | |
| serious | Abdominal injury | Injury, poisoning and procedural complications | Valsartan 80 mg | 0 | 307 | |
| serious | Abdominal injury | Injury, poisoning and procedural complications | Valsartan 160 mg | 0 | 303 | |
| serious | Liver function test abnormal | Investigations | Valsartan/Amlodipine 80/5 mg | 1 | 308 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valsartan/Amlodipine 80/5 mg | ||
| Total, all-cause mortality | Valsartan 80 mg | ||
| Total, all-cause mortality | Valsartan 160 mg | ||
| Total, other adverse events | Valsartan/Amlodipine 80/5 mg | 0 | 308 |
| Total, other adverse events | Valsartan 80 mg | 0 | 307 |
| Total, other adverse events | Valsartan 160 mg | 0 | 303 |
| Total, serious adverse events | Valsartan/Amlodipine 80/5 mg | 4 | 308 |
| Total, serious adverse events | Valsartan 80 mg | 0 | 307 |
| Total, serious adverse events | Valsartan 160 mg | 4 | 303 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00413413
GET https://conductscience.org/api/trials/v1/NCT00413413/registered