Trial · NCT00437645
Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
NCT00437645, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension. Trials, record NCT00437645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00437645
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
- NCT number
- NCT00437645
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,183 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Essential Hypertension
- Interventions
- Valsartan 160 mg capsules, Amlodipine 5 mg capsules, placebo
- First posted
- 2007-02-21
- Last updated
- 2014-11-11
- Results first posted
- 2011-02-14
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 Systolic Blood Pressure (msSBP) From Baseline to Week 8 | Baseline to Week 8 | Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. |
| Primary | Percentage of Patients With Peripheral Edema From Baseline to Week 8 | Baseline to Week 8 | Only occurrences of peripheral edema quantified as a reported adverse event coded as peripheral edema were included in the analysis. If a patient experienced more than one occurrence of peripheral edema between Day 1 and Week 8, it was only counted once in the analysis. |
| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 | Baseline to Week 8 | Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. |
| Secondary | Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12 | Baseline to Weeks 4, 8, and 12 | Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. |
| Secondary | Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12 | Baseline to Weeks 4, 8, and 12 | Systolic response was defined as msSBP \< 130 mmHg or at least a 20 mmHg reduction from baseline in msSBP at Weeks 4, 8, and 12. Blood pressure (BP) was measured at trough (24±3 hours post-dose). 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 with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were 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 Systolic Blood Pressure (msSBP) From Baseline to Week 8 | Baseline to Week 8 | Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward \[LOCF\]). | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Patients With Peripheral Edema From Baseline to Week 8 | Baseline to Week 8 | Safety population: All randomized patients. | Percentage of patients | NUMBER |
| SECONDARY | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 | Baseline to Week 8 | Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward \[LOCF\]). | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12 | Baseline to Weeks 4, 8, and 12 | Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward \[LOCF\]). | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12 | Baseline to Weeks 4, 8, and 12 | Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward \[LOCF\]). | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group24
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 Systolic Blood Pressure (msSBP) From Baseline to Week 8 | Valsartan/Amlodipine 160/5 mg | -8.01 | Standard Error 0.5944 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8 | Amlodipine 10 mg | -6.30 | Standard Error 0.6088 | mmHg | |
| Percentage of Patients With Peripheral Edema From Baseline to Week 8 | Valsartan/Amlodipine 160/5 mg | 6.6 | Percentage of patients | ||
| Percentage of Patients With Peripheral Edema From Baseline to Week 8 | Amlodipine 10 mg | 31.1 | Percentage of patients | ||
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 | Valsartan/Amlodipine 160/5 mg | -4.65 | Standard Error 0.3616 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 | Amlodipine 10 mg | -4.13 | Standard Error 0.3690 | mmHg | |
| Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12 | Valsartan/Amlodipine 160/5 mg | msSBP: Week 4 (n=576, 535) | -8.40 | Standard Error 0.5559 | mmHg |
| Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12 | Amlodipine 10 mg | msSBP: Week 4 (n=576, 535) | -6.48 | Standard Error 0.5676 | mmHg |
| Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12 | Valsartan/Amlodipine 160/5 mg | msSBP: Week 8 (n=567, 510) | -8.15 | Standard Error 0.6065 | mmHg |
| Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12 | Amlodipine 10 mg | msSBP: Week 8 (n=567, 510) | -6.11 | Standard Error 0.6266 | mmHg |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valsartan/Amlodipine 160/5 mg | 592 | |
| Overall Study | STARTED | Amlodipine 10 mg | 591 | |
| Overall Study | COMPLETED | Valsartan/Amlodipine 160/5 mg | 557 | |
| Overall Study | COMPLETED | Amlodipine 10 mg | 476 | |
| Overall Study | NOT COMPLETED | Valsartan/Amlodipine 160/5 mg | 35 | |
| Overall Study | NOT COMPLETED | Amlodipine 10 mg | 115 |
Source ClinicalTrials.gov
Adverse events66
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 | Oedema peripheral | General disorders | Valsartan/Amlodipine 160/5 mg | 43 | 592 | |
| other | Oedema peripheral | General disorders | Amlodipine 10 mg | 186 | 591 | |
| other | Headache | Nervous system disorders | Valsartan/Amlodipine 160/5 mg | 18 | 592 | |
| other | Headache | Nervous system disorders | Amlodipine 10 mg | 33 | 591 | |
| serious | Atrial fibrillation | Cardiac disorders | Valsartan/Amlodipine 160/5 mg | 1 | 592 | |
| serious | Atrial fibrillation | Cardiac disorders | Amlodipine 10 mg | 0 | 591 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Valsartan/Amlodipine 160/5 mg | 0 | 592 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Amlodipine 10 mg | 1 | 591 | |
| serious | Gastrointestinal necrosis | Gastrointestinal disorders | Valsartan/Amlodipine 160/5 mg | 0 | 592 | |
| serious | Gastrointestinal necrosis | Gastrointestinal disorders | Amlodipine 10 mg | 1 | 591 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse 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 | Amlodipine 10 mg | ||
| Total, other adverse events | Valsartan/Amlodipine 160/5 mg | 61 | 592 |
| Total, other adverse events | Amlodipine 10 mg | 201 | 591 |
| Total, serious adverse events | Valsartan/Amlodipine 160/5 mg | 11 | 592 |
| Total, serious adverse events | Amlodipine 10 mg | 8 | 591 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19196360 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Valsartan/Amlodipine 160/5 mg vs Amlodipine 10 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/NCT00437645
GET https://conductscience.org/api/trials/v1/NCT00437645/results?page=2