Hypertension
Conditions
Keywords
Hypertension, fixed drug combination, Filipinos, Amlodipine, Olmesartan medoxomil, uncontrolled hypertension, difficult to treat hypertension
Brief summary
The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
Interventions
DRUGAmlodipine + Olmesartan medoxomil
start dose is 5/20 mg, which can then be uptitrated to 5/40 mg up to 10/40 mg if BP goal is not reached during the 4 week follow-up
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Filipino hypertensive subjects ages 18-65 years old whether naive or currently taking any other anti-hypertensive or those on monotherapy using CCBs or ARBs whom they want to shift on a fixed dose combination drug
Exclusion criteria
* Patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last study drug administration (Week 12) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
| Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | Baseline, Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Baseline, Week 4, Week 8, Week 12 | — |
| Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF | Baseline, Week 12 | Based on JNC VII, the ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. The JNC VII recommended BP goal is \<140/90 mmHg and \<130/80 mmHg for participants with diabetes. |
Countries
Philippines
Participant flow
Pre-assignment details
The diagnostic criteria of hypertension (defined by Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure \[JNC VII\] as systolic blood pressure \[BP\] \>=140 mmHg and diastolic BP \>=90 mmHg) and the dosage of study medication were consistent with the investigator's routine clinical setting.
Participants by arm
| Arm | Count |
|---|---|
| Normetec Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines. | 613 |
| Total | 613 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 56 |
| Overall Study | Other | 19 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Normetec |
|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Asian | 610 Participants |
| Race/Ethnicity, Customized Unspecified | 3 Participants |
| Sex/Gender, Customized Female | 334 Participants |
| Sex/Gender, Customized Male | 277 Participants |
| Sex/Gender, Customized Unspecified | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 613 |
| serious Total, serious adverse events | 0 / 613 |
Outcome results
Primary
Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12
Population: The full analysis population included all participants who received at least 1 dose of study medication during the observation period; number analyzed=number of participants with observed value in category. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normetec | Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | Baseline: SBP | 161.6 millimeters of mercury (mmHg) | Standard Deviation 16.04 |
| Normetec | Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | Baseline: DBP | 98.9 millimeters of mercury (mmHg) | Standard Deviation 9.33 |
| Normetec | Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | Change at Week 12: SBP LOCF | -35.8 millimeters of mercury (mmHg) | Standard Deviation 16.74 |
| Normetec | Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | Change at Week12: DBP LOCF | -19.4 millimeters of mercury (mmHg) | Standard Deviation 10.39 |
Comparison: SBP with LOCF (Week 12)p-value: 095% CI: [-37.2, -34.4]t-test, 2 sided
Comparison: DBP with LOCF (Week 12)p-value: 095% CI: [-20.3, -18.6]t-test, 2 sided
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to 28 days after last study drug administration (Week 12)
Population: The safety analysis population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normetec | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 6 participants |
| Normetec | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 0 participants |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF
Time frame: Baseline, Week 4, Week 8, Week 12
Population: The full analysis population included all participants who received at least 1 dose of study medication during the observation period; number analyzed=number of participants with observed value in category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normetec | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Change at Week 4: DBP w/o LOCF | -13.2 mmHg | Standard Deviation 9.46 |
| Normetec | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Change and Week 8: SBP w/o LOCF | -33.0 mmHg | Standard Deviation 16.36 |
| Normetec | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Change at Week 4: SBP w/o LOCF | -24.7 mmHg | Standard Deviation 16.33 |
| Normetec | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Change and Week 8: DBP w/o LOCF | -17.6 mmHg | Standard Deviation 9.99 |
| Normetec | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Change and Week 12: SBP w/o LOCF | -36.3 mmHg | Standard Deviation 16.64 |
| Normetec | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Change and Week 12: DBP w/o LOCF | -19.9 mmHg | Standard Deviation 9.99 |
Comparison: SBP w/o LOCF (Week 4)p-value: 095% CI: [-26.1, -23.4]t-test, 2 sided
Comparison: SBP w/o LOCF (Week 8)p-value: 095% CI: [-34.4, -31.6]t-test, 2 sided
Comparison: SBP w/o LOCF (Week 12)p-value: 095% CI: [-37.9, -34.7]t-test, 2 sided
Comparison: DBP w/o LOCF (Week 4)p-value: 095% CI: [-14, -12.4]t-test, 2 sided
Comparison: DBP w/o LOCF (Week 8)p-value: 095% CI: [-18.4, -16.7]t-test, 2 sided
Comparison: DBP w/o LOCF (Week 12)p-value: 095% CI: [-20.8, -18.9]t-test, 2 sided
Secondary
Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF
Based on JNC VII, the ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. The JNC VII recommended BP goal is \<140/90 mmHg and \<130/80 mmHg for participants with diabetes.
Time frame: Baseline, Week 12
Population: The full analysis population included all participants who received at least 1 dose of study medication during the observation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normetec | Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF | 70.5 percentage of participants |