Trial Outcomes & Findings for Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients (NCT NCT01200407)

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

615 participants

Primary outcome timeframe

Baseline up to 28 days after last study drug administration (Week 12)

Results posted on

2021-08-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	615
Overall Study COMPLETED	533
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	56
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	4
Overall Study Other	19

Baseline Characteristics

Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normetec n=613 Participants 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.
Age, Continuous	53.7 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex/Gender, Customized Female	334 Participants n=5 Participants
Sex/Gender, Customized Male	277 Participants n=5 Participants
Sex/Gender, Customized Unspecified	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	610 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Normetec n=613 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Participants with SAEs	0 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Participants with AEs	6 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normetec n=613 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normetec n=613 Participants 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.
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
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
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
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
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
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

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis population included all participants who received at least 1 dose of study medication during the observation period.

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.

Outcome measures

Outcome measures
Measure	Normetec n=613 Participants 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.
Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF	70.5 percentage of participants Interval 66.9 to 74.1

Adverse Events

Normetec

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normetec n=613 participants at risk 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.
Ear and labyrinth disorders Vertigo positional	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)
General disorders Chest Pain	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)
General disorders Oedema peripheral	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)
Immune system disorders Drug hypersensitivity	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)
Nervous system disorders Dizziness	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)
Nervous system disorders Migraine	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)
Skin and subcutaneous tissue disorders Pruritus	0.16% 1/613 • Baseline up to 28 days after last study drug administration (Week 12)

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single enter publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER