Essential Hypertension
Conditions
Keywords
essential hypertension
Brief summary
The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.
Interventions
Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, above 18 years of age * Diagnosis of essential hypertension * Newly diagnosed, * Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period) * Written informed consent
Exclusion criteria
* Known or suspected secondary hypertension * eGFR lower than 30 mL/min * Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide) * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | At week 4 and 8 | Control rate of BP defined as BP lower than 140/90 mmHg at office visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | baseline, week 4, week 8 | Change in systolic blood pressure measured in office from baseline at week 4 and 8. |
| Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | baseline, week 4, week 8 | Change in diastolic blood pressure measured in office from baseline at week 4 and week 8. |
| Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | At week 4 and 8 | Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (\>100 mEq/day) |
| SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | At week 4 and 8 | Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
One hundred thirty patients were screened and 115 were enrolled into the trial.
Participants by arm
| Arm | Count |
|---|---|
| Amlodipine/Valsartan All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 8 |
Baseline characteristics
| Characteristic | Amlodipine/Valsartan |
|---|---|
| Age, Continuous | 55.06 years STANDARD_DEVIATION 11.22 |
| Body mass index | 31.19 kg/m^2 STANDARD_DEVIATION 5.32 |
| Diastolic blood pressure | 96.7 mmHg STANDARD_DEVIATION 12.7 |
| Heart rate | 80.15 beats/min STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 45 Participants |
| Systolic blood pressure | 164.3 mmHG STANDARD_DEVIATION 13.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 110 |
| serious Total, serious adverse events | 3 / 110 |
Outcome results
Primary
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Time frame: At week 4 and 8
Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 4 Systolic (n=100) | 47.0 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 4 Diastolic (n=100) | 78.0 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 4 Overall Blood Pressure(n=100) | 45.0 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 Systolic(n=91) | 70.3 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 Diastolic (n=91) | 82.4 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 Overall Blood Pressure (n=91) | 67.0 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 Systolic (LOCF) (n=100) | 68.0 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 Diastolic (LOCF) (n=100) | 81.0 Percentage of Participants |
| Amlodipine/Valsartan | Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 Overall Blood Pressure (LOCF) (n=100) | 65.0 Percentage of Participants |
Secondary
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
Time frame: baseline, week 4, week 8
Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Diastolic blood pressure (DBP) Day 0 (n=100) | 96.66 mmHg | Standard Deviation 12.68 |
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Diastolic blood pressure (DBP) Week 4 (n=100) | 82.0 mmHg | Standard Deviation 9.88 |
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Diastolic blood pressure (DBP) Week 8 (n=91) | 81.04 mmHg | Standard Deviation 8.66 |
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Diastolic blood pressure (DBP) Week 8 LOCF (n=100) | 81.37 mmHg | Standard Deviation 8.69 |
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Decrease in Diastolic BP Week 4 (n=100) | 14.66 mmHg | Standard Deviation 12.58 |
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Decrease in Diastolic BP Week 8 (n=91) | 15.54 mmHg | Standard Deviation 13.19 |
| Amlodipine/Valsartan | Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 | Decrease in Diastolic BP Week 8 LOCF (n=100) | 15.29 mmHg | Standard Deviation 12.73 |
Secondary
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (\>100 mEq/day)
Time frame: At week 4 and 8
Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine/Valsartan | Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 4 (n=70) | 68.6 Percentage of participants |
| Amlodipine/Valsartan | Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 (n=64) | 64.1 Percentage of participants |
| Amlodipine/Valsartan | Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 | Week 8 LOCF (n=70) | 62.9 Percentage of participants |
Secondary
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.
Time frame: At week 4 and 8
Population: All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine/Valsartan | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | SBP at Week 4 (n=70) | 140.01 mmHg | Standard Deviation 13.67 |
| Amlodipine/Valsartan | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | SBP at Week 8 (n=64) | 134.20 mmHg | Standard Deviation 13.24 |
| Amlodipine/Valsartan | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | SBP at Week 8 LOCF (n=70) | 134.84 mmHg | Standard Deviation 13.17 |
| Amlodipine/Valsartan | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | DBP at Week 4 (n=70) | 81.73 mmHg | Standard Deviation 10.26 |
| Amlodipine/Valsartan | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | DBP at Week 8 (n=64) | 81.23 mmHg | Standard Deviation 8.8 |
| Amlodipine/Valsartan | SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 | DBP at Week 8 LOCF (n=70) | 81.47 mmHg | Standard Deviation 8.91 |
Secondary
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Change in systolic blood pressure measured in office from baseline at week 4 and 8.
Time frame: baseline, week 4, week 8
Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Systolic blood pressure (SBP) Day 0 (n=100) | 164.3 mmHg | Standard Deviation 13.2 |
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Systolic blood pressure (SBP) Week 4 (n=100) | 140.17 mmHg | Standard Deviation 14.05 |
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Systolic blood pressure (SBP) Week 8 (n=91) | 134.04 mmHg | Standard Deviation 13.51 |
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Systolic blood pressure (SBP) Week 8 LOCF (n=100) | 134.71 mmHg | Standard Deviation 13.37 |
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Decrease in Systolic Week 4 (n=100) | 24.15 mmHg | Standard Deviation 18.18 |
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Decrease in Systolic Week 8 (n=91) | 30.22 mmHg | Standard Deviation 18.25 |
| Amlodipine/Valsartan | Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 | Decrease in Systolic BP Week 8 LOCF (n=100) | 29.61 mmHg | Standard Deviation 17.81 |