A Phase 3 interventional study of Valsartan 160 mg capsules and Amlodipine 5 mg capsules in Essential Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 12 sites in 12 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-11-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.
538 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.
This study's enrollment of 1,183 is above the median of 166 across 458 interventional studies indexed under Essential Hypertension.
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Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Drug: Valsartan 160 mg capsules · Drug: Amlodipine 5 mg capsules · Drug: placebo
Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Drug: Valsartan 160 mg capsules · Drug: Amlodipine 5 mg capsules · Drug: placebo
capsules
Change in Mean Sitting Systolic Blood Pressure (msSBP) From 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.
Time frame: Baseline to Week 8
Percentage of Patients With Peripheral Edema From 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.
Time frame: Baseline to Week 8
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From 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.
Time frame: Baseline to Week 8
Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From 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.
Time frame: Baseline to Weeks 4, 8, and 12
Percentage of Patients Achieving a Systolic Response at 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.
Time frame: Baseline to Weeks 4, 8, and 12
| Milestone | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| Started | 592 | 591 |
| Completed | 557 | 476 |
| Not completed | 35 | 115 |
| Withdrew: Adverse event | 15 | 84 |
| Withdrew: Withdrawal by subject | 10 | 22 |
| Withdrew: Protocol violation | 3 | 3 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Administrative problems | 2 | 1 |
| Withdrew: Lack of efficacy | 2 | 1 |
| Withdrew: Condition no longer requires study drug | 1 | 1 |
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.
| mmHg | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8 | -8.01 ± 0.5944 | -6.30 ± 0.6088 |
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.
| Percentage of patients | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| Percentage of Patients With Peripheral Edema From Baseline to Week 8 | 6.6 | 31.1 |
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.
| mmHg | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 | -4.65 ± 0.3616 | -4.13 ± 0.3690 |
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.
| mmHg | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| msSBP: Week 4 (n=576, 535) | -8.40 ± 0.5559 | -6.48 ± 0.5676 |
| msSBP: Week 8 (n=567, 510) | -8.15 ± 0.6065 | -6.11 ± 0.6266 |
| msSBP: Week 12 (n=569, 531) | -9.08 ± 0.6968 | -7.82 ± 0.7088 |
| msDBP: Week 4 (n=576, 535) | -5.05 ± 0.3559 | -4.23 ± 0.3623 |
| msDBP: Week 8 (n=576, 510) | -4.68 ± 0.3632 | -3.97 ± 0.3736 |
| msDBP: Week 12 (n=569, 531) | -5.50 ± 0.03735 | -4.90 ± 0.3785 |
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.
| Percentage of patients | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| Week 4 (n=576, 535) | 35.07 | 25.42 |
| Week 8 (n=567, 510) | 34.22 | 25.49 |
| Week 12 (n=569, 531) | 37.96 | 31.26 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Valsartan/Amlodipine 160/5 mg | — | 11/592 (1.9%) | 61/592 (10.3%) |
| Amlodipine 10 mg | — | 8/591 (1.4%) | 201/591 (34%) |
| Event | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| CholecystitisHepatobiliary disorders | 2/592 | 0/591 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/592 | 1/591 |
| Gastrointestinal necrosisGastrointestinal disorders | 0/592 | 1/591 |
| Inguinal herniaGastrointestinal disorders | 0/592 | 1/591 |
| Humerus fractureInjury, poisoning and procedural complications | 0/592 | 1/591 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/592 | 1/591 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/592 | 1/591 |
| Cerebrovascular accidentNervous system disorders | 0/592 | 1/591 |
| DysphasiaNervous system disorders | 0/592 | 1/591 |
| Neglect of personal appearancePsychiatric disorders | 0/592 | 1/591 |
| Event | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg |
|---|---|---|
| Oedema peripheralGeneral disorders | 43/592 | 186/591 |
| HeadacheNervous system disorders | 18/592 | 33/591 |
| Age, Continuous(Age (years)) | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg | Total |
|---|---|---|---|
| Overall study | 65.6 ± 7.56 | 65.4 ± 7.16 | 65.5 ± 7.36 |
| Sex: Female, Male(Participants) | Valsartan/Amlodipine 160/5 mg | Amlodipine 10 mg | Total |
|---|---|---|---|
| Female | 285 | 284 | 569 |
| Male | 307 | 307 | 614 |
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Studies of the drugs tested here: Valsartan · Amlodipine