Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Losartan (+) amlodipine; Drug: Placebo to match losartan/amlodipine tablets; Drug: Amlodipine camsylate; Drug: Placebo to match amlodipine

• Registration Number: NCT01277822
• Lead Sponsor: Organon and Co

Brief Summary

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Study Start: 2011-05-30
• Primary Completion: 2013-04-22
• Study Completion: 2013-04-22
• Results First Submitted: 2014-03-24
• Results First Submitted QC: 2014-03-24
• Results First Posted: 2014-04-24
• Status Verified: 2022-02
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine Treatment Arm	Amlodipine camsylate	2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
Losartan/amlodipine Treatment Arm	Losartan (+) amlodipine	One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
Losartan/amlodipine Treatment Arm	Placebo to match amlodipine	One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
Amlodipine Treatment Arm	Placebo to match losartan/amlodipine tablets	2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8	Baseline and Week 8	Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.

Secondary Outcome Measures

Name	Time	Method
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4	Baseline and Week 4	Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4	Baseline and Week 4	Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Change From Baseline in Ankle Circumference at Week 8	Baseline and Week 8	Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8	Baseline and Week 8	Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Percentage of Participants Who Achieve Target Blood Pressure at Week 8	Week 8	Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) \<90mmHg or sitting systolic BP (sitSBP) \<140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
Percentage of Participants Who Achieve Target Blood Pressure at Week 4	Week 4	Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) \<90mmHg or sitting systolic BP (sitSBP) \<140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
Percentage of Participants Who Had Peripheral Edema During the Study	up to 8 weeks	A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.