Trial · NCT00425373
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
NCT00425373, Phase 2, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension. Trials, record NCT00425373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00425373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
- NCT number
- NCT00425373
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,474 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Essential Hypertension
- Interventions
Valsartan + amlodipine 40/2.5 mg, Valsartan + amlodipine 40/5 mg, Valsartan + amlodipine 80/2.5 mg, Valsartan + amlodipine 80/5 mg, Valsartan 40 mg, Valsartan 80 mg, Amlodipine 2.5 mg, Amlodipine 5 mg, Placebo
- First posted
- 2007-01-23
- Last updated
- 2011-04-29
- Results first posted
- 2011-02-04
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) | At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. |
| Secondary | Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. |
| Secondary | Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8) | Baseline to end of study (Week 8) | At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. |
| Secondary | Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8) | Baseline to end of study (Week 8) | At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. |
| Secondary | Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8) | Baseline to end of study (Week 8) | At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure. |
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) | Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value. | mm Hg | 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) | Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8) | Baseline to end of study (Week 8) | Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8) | Baseline to end of study (Week 8) | Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8) | Baseline to end of study (Week 8) | Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group45
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 40/2.5 mg | -13.5 | Standard Error 0.62 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Valsartan + Amlodipine 40/5 mg | -16.5 | Standard Error 0.60 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Valsartan + Amlodipine 80/2.5 mg | -12.6 | Standard Error 0.62 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Valsartan + Amlodipine 80/5 mg | -17.0 | Standard Error 0.61 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Valsartan 40 mg | -8.5 | Standard Error 0.60 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Valsartan 80 mg | -8.8 | Standard Error 0.61 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Amlodipine 2.5 mg | -10.3 | Standard Error 0.61 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Amlodipine 5 mg | -13.4 | Standard Error 0.61 | mm Hg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) | Placebo | -4.8 | Standard Error 0.61 | mm Hg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8) | Valsartan + Amlodipine 40/2.5 mg | -16.7 | Standard Error 0.88 | mm Hg |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valsartan + Amlodipine 40/2.5 mg | 159 | |
| Overall Study | STARTED | Valsartan + Amlodipine 40/5 mg | 167 | |
| Overall Study | STARTED | Valsartan + Amlodipine 80/2.5 mg | 160 | |
| Overall Study | STARTED | Valsartan + Amlodipine 80/5 mg | 162 | |
| Overall Study | STARTED | Valsartan 40 mg | 169 | |
| Overall Study | STARTED | Valsartan 80 mg | 163 | |
| Overall Study | STARTED | Amlodipine 2.5 mg | 161 | |
| Overall Study | STARTED | Amlodipine 5 mg | 161 | |
| Overall Study | STARTED | Placebo | 166 | |
| Overall Study | COMPLETED | Valsartan + Amlodipine 40/2.5 mg | 154 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events54
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 | Nasopharyngitis | Infections and infestations | Placebo | 17 | 166 | |
| other | Nasopharyngitis | Infections and infestations | Valsartan 40 mg | 23 | 169 | |
| other | Nasopharyngitis | Infections and infestations | Valsartan 80 mg | 19 | 163 | |
| other | Nasopharyngitis | Infections and infestations | Amlodipine 2.5 mg | 12 | 161 | |
| other | Nasopharyngitis | Infections and infestations | Valsartan + Amlodipine 40/2.5 mg | 17 | 159 | |
| other | Nasopharyngitis | Infections and infestations | Valsartan + Amlodipine 80/2.5 mg | 9 | 160 | |
| other | Nasopharyngitis | Infections and infestations | Amlodipine 5 mg | 12 | 161 | |
| other | Nasopharyngitis | Infections and infestations | Valsartan + Amlodipine 40/5 mg | 20 | 167 | |
| other | Nasopharyngitis | Infections and infestations | Valsartan + Amlodipine 80/5 mg | 14 | 162 | |
| serious | Supraventricular tachycardia | Cardiac disorders | Placebo | 0 | 166 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Valsartan 40 mg | ||
| Total, all-cause mortality | Valsartan 80 mg | ||
| Total, all-cause mortality | Amlodipine 2.5 mg | ||
| Total, all-cause mortality | Valsartan + Amlodipine 40/2.5 mg | ||
| Total, all-cause mortality | Valsartan + Amlodipine 80/2.5 mg | ||
| Total, all-cause mortality | Amlodipine 5 mg | ||
| Total, all-cause mortality | Valsartan + Amlodipine 40/5 mg | ||
| Total, all-cause mortality | Valsartan + Amlodipine 80/5 mg | ||
| Total, other adverse events | Placebo | 17 | 166 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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