A Dose response study in patients with mild to moderate hypertension.

A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/04/001682

Enrollment

910

Registered

2011-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Systolic Hypertension

Interventions

Intervention1: LCZ696: The LCZ 696 compound comprises the molecular moieties AHU377 and valsartan, and sodium and water molecules in the ratio of 1:1:3:2:5 respectively. Dosage: 200 mg qd for one week

Eligibility

Inclusion criteria

Inclusion criteria: 1. Severe hypertension 2. Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy. 3. Ability to communicate and comply with all study requirements and demonstrate good medication compliance ( greater than or equal to 80 percent compliance rate) during the run-in period.

Exclusion criteria

Exclusion criteria: 1. History of angioedema, drug-related or otherwise, as reported by the patient. 2. Pregnant or nursing (lactating) women. 3. Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods. 4. History or evidence of a secondary form of hypertension. 5. Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
reduction in mean sitting systolic blood pressure (msSBP)Timepoint: Baseline and 8 weeks	—

Secondary

Measure	Time frame
changes in mean 24 hour ambulatory SBP (maSBP), mean 24 hour ambulatory DBP (maDBP), daytime and nighttime msSBP/maDBP of ascending doses of AHU377 in combination with valsartan 320mg as compared to valsartan 320mg monotherapyTimepoint: Baseline and 8 weeks;dose-response relationship in msSBP/msDBP and maSBP/maDBP lowering of ascending doses of AHU377 in combination with valsartan 320mg by sub-group analysis of age ( less than 65 and greater than or equal to 65)Timepoint: Baseline and 8 weeks;dose-response relationship in sitting diastolic blood pressure (msDBP) lowering of ascending doses of AHU377 in combination with valsartan 320 mgTimepoint: Baseline and 8 weeks;Frequency of adverse events, serious adverse events, and notable laboratory abnormalitiesTimepoint: Baseline and 8 weeks;office and ambulatory pulse pressure for all treatment groupsTimepoint: Baseline and 8 weeks	—

Measure

Time frame

changes in mean 24 hour ambulatory SBP (maSBP), mean 24 hour ambulatory DBP (maDBP), daytime and nighttime msSBP/maDBP of ascending doses of AHU377 in combination with valsartan 320mg as compared to valsartan 320mg monotherapyTimepoint: Baseline and 8 weeks;dose-response relationship in msSBP/msDBP and maSBP/maDBP lowering of ascending doses of AHU377 in combination with valsartan 320mg by sub-group analysis of age ( less than 65 and greater than or equal to 65)Timepoint: Baseline and 8 weeks;dose-response relationship in sitting diastolic blood pressure (msDBP) lowering of ascending doses of AHU377 in combination with valsartan 320 mgTimepoint: Baseline and 8 weeks;Frequency of adverse events, serious adverse events, and notable laboratory abnormalitiesTimepoint: Baseline and 8 weeks;office and ambulatory pulse pressure for all treatment groupsTimepoint: Baseline and 8 weeks

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Countries

Argentina, Canada, Hungary, India, Poland, Republic of Korea, Romania, Slovakia, United States of America

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026