Trial · NCT01001572
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
NCT01001572, Phase 3, Completed, Novartis; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension. Trials, record NCT01001572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01001572
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
- NCT number
- NCT01001572
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 932 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Essential Hypertension
- Interventions
- Valsartan/amlodipine 160/5 mg, Valsartan 160 mg, Placebo
- First posted
- 2009-10-26
- Last updated
- 2011-05-24
- Results first posted
- 2011-05-24
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 Week 8 Endpoint | Baseline and Week 8 | Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate. |
| Secondary | Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint | Baseline and Week 8 | Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate |
| Secondary | Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint | Baseline and Week 8 | The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) \< 90 mmHg or a \>= 10 mmHg reduction from baseline. |
| Secondary | Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint | Week 8 | The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) \< 90 mmHg. |
| Secondary | Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint | Week 8 | The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) \< 140/90 mmHg. |
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 Week 8 Endpoint | Baseline and Week 8 | Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint | Baseline and Week 8 | Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint | Baseline and Week 8 | Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint | Week 8 | Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint | Week 8 | Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
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 Week 8 Endpoint | Valsartan/Amlodipine 160/5 mg | -10.3 | Standard Error 0.39 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint | Valsartan 160 mg | -6.6 | Standard Error 0.40 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint | Valsartan/Amlodipine 160/5 mg | -14.9 | Standard Error 0.61 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint | Valsartan 160 mg | -7.0 | Standard Error 0.61 | mmHg | |
| Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint | Valsartan/Amlodipine 160/5 mg | 70.1 | Percentage of Participants | ||
| Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint | Valsartan 160 mg | 52.6 | Percentage of Participants | ||
| Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint | Valsartan/Amlodipine 160/5 mg | 65.9 | Percentage of Participants | ||
| Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint | Valsartan 160 mg | 50.8 | Percentage of Participants | ||
| Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint | Valsartan/Amlodipine 160/5 mg | 61.3 | Percentage of Participants | ||
| Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint | Valsartan 160 mg | 39.3 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-Blind Valsartan 160 mg | STARTED | Single-Blind Run -In Valsartan 160 mg | 932 | |
| Single-Blind Valsartan 160 mg | STARTED | Valsartan/Amlodipine 160/5 mg | 0 | |
| Single-Blind Valsartan 160 mg | STARTED | Valsartan 160 mg | 0 | |
| Single-Blind Valsartan 160 mg | COMPLETED | Single-Blind Run -In Valsartan 160 mg | 654 | |
| Single-Blind Valsartan 160 mg | COMPLETED | Valsartan/Amlodipine 160/5 mg | 0 | |
| Single-Blind Valsartan 160 mg | COMPLETED | Valsartan 160 mg | 0 | |
| Single-Blind Valsartan 160 mg | NOT COMPLETED | Single-Blind Run -In Valsartan 160 mg | 278 | |
| Single-Blind Valsartan 160 mg | NOT COMPLETED | Valsartan/Amlodipine 160/5 mg | 0 | |
| Single-Blind Valsartan 160 mg | NOT COMPLETED | Valsartan 160 mg | 0 | |
| Double-Blind Treatment Phase | STARTED | Single-Blind Run -In Valsartan 160 mg | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events2
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 | Uterine polyp | Reproductive system and breast disorders | Valsartan/Amlodipine 160/5 mg | 0 | 329 | |
| serious | Uterine polyp | Reproductive system and breast disorders | Valsartan 160 mg | 1 | 325 |
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 160/5 mg | ||
| Total, all-cause mortality | Valsartan 160 mg | ||
| Total, other adverse events | Valsartan/Amlodipine 160/5 mg | 0 | 329 |
| Total, other adverse events | Valsartan 160 mg | 0 | 325 |
| Total, serious adverse events | Valsartan/Amlodipine 160/5 mg | 0 | 329 |
| Total, serious adverse events | Valsartan 160 mg | 1 | 325 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Valsartan/Amlodipine 160/5 mg vs Valsartan 160 mg: 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/NCT01001572
GET https://conductscience.org/api/trials/v1/NCT01001572/flow?page=2